CHILDRENS MAPAP- acetaminophen tablet, chewable 
Major Pharmaceuticals

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.

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Active ingredient

(in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporaily relieves minor aches and pains due to:
  • the common cold
  • headache
  • flu
  • sorethroat
  • toothache
  • temporarily reduces fever

Warnings

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 drug containing acetaminophen (prescription or nonprescription). 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

Ask a doctor before use if your child has

  • liver disease

Ask a doctor or pharmacist before use if your child is

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

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.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
 Weight (lb) Age (yr) Tablets
 Under 24 Under 2 Ask a doctor
 24-35 2-3 2
 36-47 4-5 3
 48-59 6-8 4
 60-71 9-10 5
 72-95 11 6

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethelene, povidone, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

MAJOR®

See New Warnings Information

NDC 0904-5791-46

*Compare to the active ingredient in

Children's Tylenol® Meltaways

Children's

Mapap®

Acetaminophen

Fever reducer / Pain reliever

ASPIRIN FREE • IBUPROFEN FREE

AGES 2-6

Rapid Tabs

30 Tablets, 80 mg EACH

Grape Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844      REV0410B45201

Distributed by Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA        M-17

Rev. 05/10

Re-order No. 006446

Product Packaging

Product Packaging

CHILDRENS MAPAP 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5791
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTROSE 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5791-461 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/06/2004
Labeler - Major Pharmaceuticals (191427277)

Revised: 04/2011
 
Major Pharmaceuticals