Label: ACETAMINOPHEN - acetaminophen tablet, chewable
- NDC Code(s): 54868-5625-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5256
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 6, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient (in each chewable tablet)
Acetaminophen 80 mgClose
Pain Reliever/Fever ReducerClose
Temporarily relieves minor aches and pain due to:
■ The common cold ■ Flu ■ Headache ■ Sore throat
Temporarily reduces fever.Close
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use ■ with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Stop use and ask a doctor if ■ Pain gets worse or lasts more than 5 days ■ Fever gets worse or lasts more than 3 days ■ New symptoms occur ■ Redness or swelling is present
These could be signs of a serious condition.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
■ This products does not contain directions or complete warnings for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.
Weight Age Tablets Under 24 lbs
Under 2 years
Ask a doctor
- Other Information
- Phenylketonurics: Contain Phenylalanine 14 mg per tablet
- Do not use if imprinted safety seal under cap is broken or missing
- Store at room temperature in a dry place
- Inactive Ingredients
Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.Close
Adverse Drug Event Call: (800) 616-2471
- Principal Display Panel
*Compare to the active ingredient in Children's Chewable Tylenol®
Acetaminophen Chewable Tablets
30 Tablets, 80 mg EACH
Fever reducer/ Pain reliever
ASPIRIN FREE ● IBUPROFEN FREE
See New Warnings Information
- INGREDIENTS AND APPEARANCE
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5625(NDC:0904-5256) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color pink Score no score Shape ROUND (ROUND BICONVEX TABLET) Size 10mm Flavor Imprint Code 1G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5625-0 1 in 1 CARTON 1 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 06/29/2006 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel