Label: CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable
Contains inactivated NDC Code(s)
NDC Code(s): 68151-2262-4
- Packager: Carilion Materials Management
- This is a repackaged label.
- Source NDC Code(s): 0904-5256
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 23, 2011
If you are a consumer or patient please visit this version.
- Active Ingredient (in each chewable tablet)
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. Liver 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. Sore throat warning:
■ 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. Do not use
■ 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 Stop use and ask a doctor if
These could be signs of a serious condition.
■ ■ 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. This products does not contain directions or complete warnings for adult use.
Weight Age Tablets Under 24 lbs
Under 2 years
Ask a doctor
- Other Information
- Inactive Ingredients
- Mapap Acetaminophen 80mg chw TAB
INGREDIENTS AND APPEARANCE
CHILDRENS CHEWABLE MAPAP
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68151-2262(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) POVIDONES (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:68151-2262-4 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/04/2011 Labeler - Carilion Materials Management (079239644) Registrant - Carilion Materials Management (079239644) Establishment Name Address ID/FEI Business Operations Carilion Materials Management 079239644 REPACK(68151-2262)