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.

----------

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

Weight Age Dosage
Under 24 lbs Under 2 years Ask a doctor
24-35 lbs 2-3 years 2 tablets
36-47 lbs 4-5 years 3 tablets
48-59 lbs 6-8 years 4 tablets
60-71 lbs 9-10 years 5 tablets
72-95 lbs 11 years 6 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 Type HUMAN OTC DRUG Item Code (Source) 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)
D&C RED NO. 27 (UNII: 2LRS185U6K)
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:0904-5256-46 1 in 1 CARTON 05/04/2011 11/30/2020
1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 05/04/2011 11/30/2020
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