Quantcast

Childrens Tylenol Recall

Get the WebProNews Newsletter:
[ Business]

McNeil Consumer & Specialty Pharmaceuticals announced a recall of a number of their Children’s Tylenol products. The voluntary recall includes all lots and all flavors of Children’s TYLENOL Meltaways 80 mg packaged in bottles and blisters, Children’s TYLENOL SoftChews 80 mg packaged in blisters, and Jr. TYLENOL Meltaways 160 mg packaged in blisters.

Some of the blister packages were designed to be convenient for parents who need dosing flexibility depending on the age or weight of the child. The package design includes blister cavities that contain one tablet while other cavities contain two tablets. Concerns have been raised that labeling on the carton and on the back of the two-tablet cavities could suggest to the consumer that two tablets provide a total of 80 mg of the active ingredient, acetaminophen, when two tablets would actually provide 160 mg of acetaminophen.

Consumers should know that each tablet contains 80 mg of this active ingredient. Each tablet is imprinted with the number "80" to reflect this amount. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

In addition, some Children's TYLENOL Meltaways 80 mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton may be confusing to some consumers in figuring out the proper dosage.

The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet 80 mg of acetaminophen. The dosage directions should guide caregivers on the bottle label for the correct number of individual tablets to be given based on the child's age and weight.

Concerns have also been raised that the carton labeling for Jr. TYLENOL Meltaways 160 mg may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen.

Consumers should know that each tablet contains 160 mg of acetaminophen. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage when taking the product for fever or pain relief over the course of the three- or five-day period specified by the labeling.

McNeil is working with the U.S. Food and Drug Administration in this recall and in the effort to alert consumers and retailers nationwide about this issue. Consumers or retailers who have questions or concerns about a product described in this alert should contact McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.TYLENOL.com. The website contains written material and photos of the product and the packaging. Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/.

Some people might remember the tragic bout Tylenol back in the 80s when someone poisoned some bottles of Tylenol several people died. The end results were improvement in the packaging and safety of not just Tylenol but man over-the-counter medicines.

John Stith is a staff writer for WebProNews covering technology and business.

Childrens Tylenol Recall
Comments Off
Top Rated White Papers and Resources

Comments are closed.

Children’s Tylenol Recall
Sign Up For The Free Newsletter
  • Sidebar Bottom