Major Children's Chewable Mapap

Childrens Chewable Mapap by

Drug Labeling and Warnings

Childrens Chewable Mapap by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS CHEWABLE MAPAP- acetaminophen tablet, chewable 
A-S Medication Solutions

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

  • temporarily relieves minor aches and pain due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • 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

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

  • skin reddening
  • blisters
  • rash

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

  • 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 dose (see overdose warning)

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: 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

  • 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 last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.
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

  • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
  • 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.

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

HOW SUPPLIED

Product: 50090-0427

Acetaminophen

Label Image
CHILDRENS CHEWABLE MAPAP 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-0427(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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE, UNSPECIFIED (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: 50090-0427-030 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201409/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/04/201109/30/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0427)

Revised: 1/2020
 
A-S Medication Solutions