CHILDRENS CHEWABLE 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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Major Children's Chewable Mapap

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Purposes

Pain Reliever/Fever Reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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

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 dose (see overdose warning)

Stop use and ask a doctor if

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: 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.

Directions

WeightAgeDosage
Under 24 lbsUnder 2 yearsAsk a doctor
24-35 lbs2-3 years2 tablets
36-47 lbs4-5 years3 tablets
48-59 lbs6-8 years4 tablets
60-71 lbs9-10 years5 tablets
72-95 lbs11 years6 tablets

Other information

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.

Questions or comments?

Call: (800) 616-2471

Distributed by:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

LIVONIA, MI 48152

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

MAJOR®
NDC 0904-5256-46
See New Warnings Information
Children's Chewable
Mapap Acetaminophen
Fever reducer/ Pain reliever

ASPIRIN FREE ● IBUPROFEN FREE

NATURAL & ARTIFICIAL BERRY FLAVORS
30 Tablets, 80 mg EACH

AGES 2-11

Major 0904-5256-46

CHILDRENS CHEWABLE MAPAP 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5256
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Product Characteristics
ColorpinkScoreno score
ShapeROUND (ROUND BICONVEX TABLET) Size10mm
FlavorImprint Code 1G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5256-461 in 1 CARTON05/04/201111/30/2020
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/04/201111/30/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2018
Document Id: 7482ddf8-8343-3818-e053-2991aa0a5778
Set id: 5b3391d9-0d16-4378-b98b-ac13de7d1004
Version: 4
Effective Time: 20180828
 
Major Pharmaceuticals