advisory vs. Rustan's supermarket
On July 18, 2010, the security guard at an entrance to said store, at Ayala Center, Makati, didn't inspect my luggage/subject said luggage to scanning with metal
detector. Said luggage was large enough to contain grenades and firearms. Then, a person at the package counter of said store, accepted said luggage for deposit
without first inspecting the contents of said luggage/subjecting the contents of said luggage to scanning with metal detector. Then, a guard at the entrance to the
inner part of said store allowed me to bring my shoulder bag to said inner part of said store without first inspecting the inside of said bag or scanning said bag
with a metal detector. Then said store sold me an imported product without the required name and address of the importer of said product. The sales invoice issued
to me was numbered 011359.

Lax security at SM Makati at Ayala Center, Makati
On July 18, 2010, two guards at an entrance to said building, didn't inspect my luggage/didn't subject said luggage to scanning with metal detector. One of said
guards was identified as "Asuncion". Said luggage was large enough to contain grenades and firearms. After I entered said building, I went to SM Supermarket at said building, and left my luggage at the package counter of said store. The employee at said counter accepted said luggage without first inspecting said luggage
or subjecting said luggage to scanning with metal detector. The sales invoice issued was numbered 6458712729.


Advisory to residents of Makati, people who go to Makati. An employee identified as Marjorie A. De Veyra Acting City Administrator Office of the City Administrator
City of Makati. Im a ;etter dated October 6, 2009, said alleged Acting City Administrator of the Office of the City Administrator of Makati, stated: "This has
reference to your letter dated August 5, 2009 pertaining to your complaints on the following matters: 1. Security lapses at the entrances of Glorietta, Park
Square 1, and SM Makati malls. Up to July 18, 2010, said De Veyra has not provided me with proof that she requested persons in charge of said entities to take
corrective measures regarding said security lapses.

advisory vs. "Vissia Marie P. Aldon
City Personnel Officer" City of Makati
The following statements, in the letter below, which I received, are untrue: "Attached are copies of our correspondence to the City Health Officer and Makati
Police Chief".


Acetaminophen
http://www.nlm.nih.gov/medlineplus/druginfo/meds/a681004.html
* Why is this medication prescribed?
* How should this medicine be used?
* Other uses for this medicine
* What special precautions should I follow?
* What special dietary instructions should I follow?
* What should I do if I forget a dose?
* What side effects can this medication cause?

* What storage conditions are needed for this medicine?
* In case of emergency/overdose
* What other information should I know?
* Brand names
* Brand names of combination products


Why is this medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
How should this medicine be used?
Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), drops (concentrated liquid), extended-release (long-acting) tablet, and orally disintegrating tablet (tablet that dissolves quickly in the mouth), to take by mouth, with or without food. Acetaminophen also comes as a suppository to use rectally. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen exactly as directed. Do not take more or less of it or take it more often than directed on the package label or prescribed by your doctor. Taking more than the recommended amount may cause damage to your liver.
If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Drops made for infants are more concentrated (much more medication in each drop) than liquids made for older children. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don't know your child's weight, give the dose that matches your child's age. Ask your child's doctor if you don't know how much medication to give your child.
Acetaminophen comes in combination with other medications to treat cough and cold symptoms. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.
Place the orally disintegrating tablet ('Meltaways') in your mouth and allow to dissolve or chew it before swallowing.
Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided by the manufacturer to measure each dose of the solution or suspension, and use the dosing device provided to measure each dose of the drops. Use the dosing device to slowly release the drops directly into the child's mouth near the inner cheek. Do not mix the drops with baby formula.
To insert an acetaminophen suppository into the rectum, follow these steps:

* Remove the wrapper.
* Dip the tip of the suppository in water.
* Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
* Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in infants and children and 1 inch (2.5 centimeters) in adults. Hold it in place for a few moments.
* Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.

Stop taking acetaminophen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, including redness or swelling, your pain lasts for more than 10 days, or your fever gets worse or lasts more than 3 days. Also stop giving acetaminophen to your child and call your child's doctor if your child develops new symptoms, including redness or swelling, or your child's pain lasts for longer than 5 days, or fever get worse or lasts longer than 3 days.
Do not give acetaminophen to a child who has a sore throat that is severe or does not go away, or that occurs along with fever, headache, rash, nausea, or vomiting. Call the child's doctor right away, because these symptoms may be signs of a more serious condition.
Other uses for this medicine Return to top
Acetaminophen may also be used in combination with aspirin and caffeine to relieve the pain associated with migraine headache.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow? Return to top
Before taking acetaminophen,

* tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
* do not take two or more products that contain acetaminophen at the same time. Many prescription and nonprescription medications contain acetaminophen in combination with other medications. Read the package labels or ask your doctor or pharmacist to be sure that you do not take more than one product that contains acetaminophen at a time.
* tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants ('blood thinners') such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
* tell your doctor if you have any serious medical condition.
* tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
* if you drink three or more alcoholic beverages every day, ask your doctor if you should take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
* you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
* if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame. a source of phenylalanine.

What special dietary instructions should I follow? Return to top
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose? Return to top
This medication is usually taken as needed. If your doctor has told you to take acetaminophen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause? Return to top
Acetaminophen may cause side effects.
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

* rash
* hives
* itching
* swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
* hoarseness
* difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine? Return to top
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose Return to top
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms. Symptoms of overdose may include:

* nausea
* vomiting
* loss of appetite
* sweating
* extreme tiredness
* unusual bleeding or bruising
* pain in the upper right part of the stomach
* yellowing of the skin or eyes
* flu-like symptoms

What other information should I know? Return to top
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen.
Ask your pharmacist any questions you have about acetaminophen.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand names Return to top

* Acephen®
* Anacin® Aspirin Free Maximum Strength Tablets®
* Capital® and Codeine
* Endocet®
* Excedrin P.M.® Caplets®
* Excedrin P.M.® Geltabs®
* Excedrin P.M.® Tablets
* Excedrin® Extra-Strength Caplets®
* Excedrin® Extra-Strength Tablets
* Excedrin® Migraine Caplets®
* Excedrin® Migraine Geltabs
* Excedrin® Migraine Tablets
* FeverAll®
* FeverAll® Infants'
* FeverAll® Junior Strength

* Gelpirin®
* Genapap®
* Genapap® Children's
* Genapap® Drops Infant's
* Genapap® Extra Strength Caplets®
* Genapap® Extra Strength Tablets
* Genapap® Gel-Coat Caplets®
* Genebs®
* Genebs® Extra Strength Caplets®
* Genebs® Extra Strength Tablets
* Goody's® Extra Strength Tablets
* Goody's® Fast Pain Relief Tablets
* Goody's® Headache Powders
* Liquiprin® Drops
* Roxicet®

* Supac®
* Tylenol®
* Tylenol® Arthritis Pain Extended Relief Caplets®
* Tylenol® Meltaways
* Tylenol® Concentrated Drops Infant's
* Tylenol® Extra Strength Adult
* Tylenol® Extra Strength ®
* Tylenol® Extra Strength Gelcaps®
* Tylenol® Extra Strength Geltabs®
* Tylenol® Extra Strength Tablets
* Tylenol® Meltaways Junior Strength
* Tylenol® Suspension Children's
* Tylox®
* Vanquish® Caplets®
* Wygesic®



Brand names of combination products Return to top

* Allerest® No Drowsiness (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Axocet® (containing Acetaminophen and Butalbital)
* Benadryl® Severe Allergy and Sinus Headache Maximum Strength Caplets® (containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride)
* Bupap® (containing Acetaminophen and Butalbital)
* Dristan® Cold No Drowsiness Formula Maximum Strength Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Duradrin® (containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate)
* Excedrin® Aspirin-Free Caplets® (containing Acetaminophen and Caffeine)
* Excedrin® Aspirin-Free Geltabs® (containing Acetaminophen and Caffeine)
* Excedrin® Quicktabs® (containing Acetaminophen and Caffeine)
* I.D.A.® (containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate)
* Midol® Menstrual Formula Maximum Strength Caplets® (containing Acetaminophen, Caffeine, and Pyrilamine Maleate)
* Midol® Menstrual Formula Maximum Strength Gelcaps® (containing Acetaminophen, Caffeine, and Pyrilamine Maleate)
* Midol® PMS Maximum Strength Caplets® (containing Acetaminophen, Pamabrom, and Pyrilamine Maleate)
* Midol® PMS Maximum Strength Gelcaps® (containing Acetaminophen, Pamabrom, and Pyrilamine Maleate)
* Midol® Teen Menstrual Formula Caplets® (containing Acetaminophen and Pamabrom)
* Midrin® (containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate)
* Ornex® Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Ornex® Maximum Strength Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Pamprin® Maximum Pain Relief Caplets® (containing Acetaminophen, Magnesium Salicylate, and Pamabrom)
* Pamprin® Multi-Symptom (containing Acetaminophen, Pamabrom, and Pyrilamine Maleate)
* Percogesic® (containing Acetaminophen and Phenyltoloxamine Citrate)
* Percogesic® Extra Strength Caplets® (containing Acetaminophen and Diphenhydramine Hydrochloride)
* Phrenilin® (containing Acetaminophen and Butalbital)
* Phrenilin® Forte (containing Acetaminophen and Butalbital)
* Premsyn PMS® Caplets® (containing Acetaminophen, Pamabrom, and Pyrilamine Maleate)

* Sedapap® (containing Acetaminophen and Butalbital)
* Sinarest® No Drowsiness Tablets (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Sine-Off® Maximum Strength No Drowsiness Formula Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Sinutab® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Sinutab® Sinus Medication Maximum Strength Without Drowsiness Tablets (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Sominex® Pain Relief Formula (containing Acetaminophen and Diphenhydramine Hydrochloride)
* St. Joseph® Cold Tablets for Children (containing Acetaminophen and Phenylpropanolamine Hydrochloride)
* Sudafed® Sinus & Headache Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Sudafed® Sinus & Headache Maximum Strength Tablets (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Tylenol® Allergy Sinus NightTime Maximum Strength Caplets® (containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride)
* Tylenol® Flu NightTime Maximum Strength Gelcaps® (containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride)
* Tylenol® PM Extra Strength Caplets® (containing Acetaminophen and Diphenhydramine Hydrochloride)
* Tylenol® PM Extra Strength Gelcaps® (containing Acetaminophen and Diphenhydramine Hydrochloride)
* Tylenol® PM Extra Strength Geltabs® (containing Acetaminophen and Diphenhydramine Hydrochloride)
* Tylenol® Sinus Geltabs® Maximum Strength Tablets (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Tylenol® Sinus Medication Maximum Strength Geltabs® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Tylenol® Sinus Medication Maximum-Strength Caplets® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Tylenol® Sinus Medication Maximum-Strength Gelcaps® (containing Acetaminophen and Pseudoephedrine Hydrochloride)
* Tylenol® with Codeine Elixir
* Tylenol® with Codeine No. 3
* Tylenol® with Codeine No. 4
* Tylenol® Women's Caplets® (containing Acetaminophen and Pamabrom)
* Ultracet® (containing Acetaminophen and Tramadol Hydrochloride)
* Women's Tylenol® Menstrual Relief Caplets® (containing Acetaminophen and Pamabrom)



Last Revised - 03/01/2010
Browse Drugs and Medicines


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American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS® Consumer Medication Information. © Copyright, 2010. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

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American Society of Health-System Pharmacists, Inc. Disclaimer - http://www.nlm.nih.gov/medlineplus/ashpdisclaimer.html

AHFS® Consumer Medication Information. © Copyright, 2010. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.



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U.S. National Library of Medicine8600 Rockville Pike, Bethesda, MD 20894U.S. Department of Health and Human ServicesNational Institutes of Health
Page last updated 13 July 2010



Acetaminophen and Liver Injury: Q & A for Consumers
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm168830.htm
On June 29 and 30, 2009, FDA held an advisory committee meeting in Adelphi, Md., about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products. For more information about the meeting, visit the Advisory Committee Web page.5

Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in relieving pain and fever is widely known. This drug is generally considered safe when used according to the directions on its labeling. But taking more than the recommended amount can cause liver damage, ranging from abnormalities in liver function blood tests, to acute liver failure, and even death.

Q: What is acetaminophen?

A: Acetaminophen (pronounced: a·seet·aminofen), is an active ingredient found in many OTC and prescription medicines to help relieve pain and reduce fever.

It is also found in combination with other active ingredients, called combination medicines, which treat conditions such as:

* symptoms of colds and flu
* allergy
* sleeplessness

Medicines containing acetaminophen are available in many forms, including drops, syrups, capsules, and pills.

Many people call OTC acetaminophen by a brand name, Tylenol. Others may know Percocet or Vicodin, which are prescription brand names that contain acetaminophen and other active ingredients to help relieve pain.

You might see acetaminophen abbreviated as “APAP” on prescription medicines.

In other countries, acetaminophen may have a different name. For example, acetaminophen is known as paracetamol in the United Kingdom.

Q. Are there risks from taking too much acetaminophen?

A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.

You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.

Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:

* Follow dosing directions and never take more than directed; even a small amount more than directed can cause liver damage.
* Don’t take acetaminophen for more days than directed.
* Don’t take more than one medicine that contains acetaminophen at a time. For example, your risk of liver damage goes up if you take a medicine that contains acetaminophen to treat a headache, and while that medicine is still working in your body, you take another medicine that contains acetaminophen to treat a cold.

Q: How can I tell which medicines contain acetaminophen?

A: Medicines have ingredients listed on their labels. On OTC medicines, check the “Drug Facts” label under the section called Active Ingredients. If your medicine contains acetaminophen, it will be listed in this section. On prescription medicine containers, the label will say “acetaminophen” or “APAP.”

Q: When should I talk to a doctor before taking acetaminophen?

A: Talk to your doctor before taking acetaminophen if you

* drink alcohol (three or more drinks every day)
* have liver disease

Under these conditions, taking acetaminophen puts you at greater risk of getting liver damage, even when taking acetaminophen at the recommended dose.

If you take the blood thinner warfarin, you should also talk to your doctor before taking acetaminophen because taking warfarin and acetaminophen together may raise your risk of bleeding.

Q: How can I safely take acetaminophen?

A: Follow this advice to take acetaminophen safely:

* Read all the information given to you by your doctor and follow directions.
* Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
* Be sure you understand the following:
- the dose, which is how much acetaminophen you can take at one time
- how many hours you must wait before taking another dose of acetaminophen
- how many doses of acetaminophen you can take safely each day
- when to stop taking acetaminophen and ask a doctor for help
* Never take more than directed, even if your pain or fever isn’t any better. Taking more acetaminophen than directed can put you at risk for liver damage.
* Never take more than one medicine that contains acetaminophen. Check the active ingredients of all your medicines to make sure you are taking no more than one medicine containing acetaminophen at a time.

Q: How can I safely give acetaminophen to my child?

A: You can safely give acetaminophen to infants, children, and teenagers if you

* Check the active ingredients in the other medicines that your child is taking (or that your child may take) to make sure they don’t contain the active ingredient acetaminophen. Your child should never be taking more than one medicine containing acetaminophen at a time.
* Read all the information given by your child’s doctor and follow directions.
* Read the information on the OTC “Drug Facts” label or on the prescription label and follow directions.
* Choose the right medicine based on your child’s weight and age. On OTC medicines, the Directions section of the “Drug Facts” label tells you:
- if the medicine is right for your child
- how much medicine to give
- how many hours you must wait before giving another dose
- when to stop giving acetaminophen and ask a doctor for help

If a dose for your child’s weight or age is not listed on the label, or you can’t tell how much to give, ask your pharmacist or doctor what to do.

* Use the measuring tool that comes with the medicine. It will give the exact dose. If you don’t have the right measuring tool, ask a pharmacist.
* Don’t use a spoon that’s meant to be used for cooking or eating. A spoon should not be used to measure medicine because it may give the wrong amount.
* Never give more than one medicine that contains acetaminophen. If you give more, it could harm your child.

Prevent medicine accidents:

* Keep a record of the medicines you give your child. Write down the dose and time when you give the medicine. This will help everyone who cares for your child know how much medicine your child has had. This will help everyone avoid giving an extra dose by mistake.
* Keep medicine where it can’t be seen or reached by children and pets; a locked box, cabinet, or closet is best.

Q: What should I do if the pain or fever doesn’t get better after taking acetaminophen as directed?

A: Take the medicine only as directed. Don’t take more. If the medicine doesn’t help you feel better, talk to your doctor, nurse, or pharmacist.

Q: What should I do if I took too much acetaminophen? What should I do if I gave too much acetaminophen to my child?

A: Don’t wait! Call 9-1-1 or Poison Control at 1-800-222-1222 right away to find out what to do. The signs or symptoms of liver damage may not be noticeable for hours or even days after taking acetaminophen. By the time you notice changes, the liver damage may be severe and could lead to death.

Q: Where can I get more information on acetaminophen?

A:

* Talk to a doctor, nurse, or pharmacist.
* Visit FDA’s consumer Web pages:

Don’t Overdo It with Acetaminophen (video)6

Safe Use of Over-the-Counter Pain Relievers and Fever Reducers7

A Guide to Safe Use of Pain Medicine8

* Contact the FDA at 1-888-INFO-FDA.
* Or, e-mail questions to FDA at druginfo@fda.hhs.gov

This article appears on FDA’s Consumer Updates page9, which features the latest on all FDA-regulated products.

Date Posted: June 24, 2009


Links on this page:

1. /downloads/ForConsumers/ConsumerUpdates/UCM172664.pdf
2. http://service.govdelivery.com/service/subscribe.html?code=USFDA_9
3. /AboutFDA/ContactFDA/StayInformed/RSSFeeds/Consumers/rss.xml
4. /ForConsumers/ConsumerUpdates/ucm174198.htm
5. /AdvisoryCommittees/Calendar/ucm143083.htm
6. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=87#9
7. /Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/SafeUseofOver-the-CounterPainRelieversandFeverReducers/default.htm
8. /ForConsumers/ConsumerUpdates/ucm095673.htm
9. /ForConsumers/ConsumerUpdates/default.htm

Page Last Updated: 07/19/2010

CPSC Proposes New Rules for Full-Size and Non-Full-Size Cribs
http://www.cpsc.gov/cpscpub/prerel/prhtml10/10301.html
FOR IMMEDIATE RELEASE
July 14, 2010
Release #10-301 CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC Proposes New Rules for Full-Size and Non-Full-Size Cribs
Proposed standard to address drop side and mattress support hazards

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) voted (5 to 0) today to approve proposed new mandatory standards to address the hazards posed by full-size and non-full-size cribs.

Serious safety hazards with cribs have ranged from drop-side hardware or other drop-side entrapment issues to failures of the mattress support and detachment or breakage of the crib slats. All of these defects can create hazardous gaps allowing a baby to become entrapped and suffocate or fall out of the crib.

The Consumer Product Safety Improvement Act of 2008 (CPSIA) directs CPSC to issue mandatory safety standards for durable infant or toddler products. CPSC’s notice of proposed rulemaking ("NPR") for cribs includes:

1. a standard for full-size cribs that is substantially the same as ASTM F 1169-10, Standard Consumer Safety Specification for Full-Size Baby Cribs, with one modification . The one modification that CPSC is proposing to the ASTM full-size crib standard would require cribs to be tested without the re-tightening of screws between tests in order to ensure that the tests reflect the lifetime use of the crib; and

2. a standard for non-full-size cribs that is substantially the same as ASTM F 406-10, Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards, with certain modifications. These modifications include adding certain requirements that apply to full-size cribs, such as the mattress support performance requirement, the side-impact test, and the order in which performance tests are to be done, applicable to non-full-size cribs so that the new standard for non-full-size cribs is more stringent. The proposal also would restore movable side latch tests to the non-full-size crib standard and would clarify that the proposal does not extend to play yards.

Through close collaboration with ASTM International, consumer groups, industry and other juvenile product experts, improved consensus standards were approved June 1, 2010, that incorporated key safety requirements recommended by CPSC staff. The ASTM standards and the proposed CPSC standards contain design requirements that essentially prohibit traditional drop sides (up and down movement of an entire side of the crib).

CPSC staff is working to finalize the proposed mandatory crib standards in 2010.

CPSC Commissioner statements attached to this release: Chairman Inez M. Tenenbaum (pdf), Commissioner Nancy A. Nord (pdf), and Commissioner Anne M. Northup (pdf)


FDA Warns of Rx Drug in Weight-Loss Supplement
http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/21238

By Cole Petrochko, Staff Writer, MedPage Today
Published: July 19, 2010
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WASHINGTON -- An unapproved supplement marketed as a "Natural Herb for Weight Loss" contains undeclared amounts of the prescription diet drug sibutramine -- which can increase risk of heart attack and stroke, an FDA analysis found.

The FDA has not approved the Slim-30 Herb Supplement and, in a statement posted on its website, recommended that consumers not use the product and return any bottles of the supplement capsules for a full refund. The safety and efficacy of the product are unproven, the agency said.

Sibutramine can considerably increase blood pressure and/or pulse rate in some patients. The FDA had warned that people with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke should not take sibutramine. (See FDA Adds Cardio Warnings to Weight-Loss Drug)

Slim-30 Herb Supplement is sold to distributors, retailers, and directly to patients through the Internet.

U.S. distributor J & H Besta Corp. announced a voluntary recall of the product following FDA analysis of the capsules.

The product is sold in 30 capsule bottles with a UPC code of 8 31457 005009 2 and a lot code of 032009.

No adverse events have been reported from use of the supplement, prepared statements from the FDA and the product's distributor said.

J & H Besta Corp. is located in Hicksville, N.Y.




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