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Childrens MAPAP Acetaminophen

Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Major
NDC Code: 0904-1985

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.

Childrens MĀPAP® Acetaminophen Liquid

Drug Facts

Active ingredient
(in each TSP (5 mL))

Acetaminophen 160 mg

Purpose

Fever reducer-Pain reliever

Uses

Temporarily relieves minor aches and pains 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

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 product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

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.

Stop use and ask a doctor if

  • pain gets worse or last for more than 5 days
  • fever gets worse or last for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use

Keep out of the 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult use
  • find right dose on chart
  • if possible, use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours
  • do not use more than 5 doses in 24 hours
WeightAgeDose
under 24 lbsUnder 2 yearsask a doctor
24 to 35 lbs2 to 3 years1 TSP (5 mL)
36 to 47 lbs4 to 5 years1 1/2 TSP (7.5 mL)
48 to 59 lbs6 to 8 years2 TSP (10 mL)
60 to 71 lbs9 to 10 years2 1/2 TSP (12.5 mL)
72 to 95 lbs11 years3 TSP (15 mL)

Other information
  • Each TSP(5 mL) contains: sodium 1mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.
  • store at 20° - 25°C (68° – 77°F)
  • this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Inactive ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sodium saccharin,sorbitol

Questions?

To Report Adverse Drug Event call 1-800-616-2471 Weekdays, 9AM - 5PM Eastern Time

PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton

NDC 0904-1985-20
TAMPER EVIDENT

MAJOR®

Children's
FEVER REDUCER-PAIN RELIEVER
Māpap®
ACETAMINOPHEN LIQUID

Fast, Effective Relief
of Children's
Fever and Pain

  • Alcohol Free
  • Aspirin Free
  • Cherry Flavor

See New Warnings Information

COMPARE TO the active
ingredient of TYLENOL®* LIQUID

4 Fl. OZ. (118mL)
80 mg per 1/2 teaspoonful (160 mg per 5 mL)

CHILDRENS MAPAP ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1985
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Sorbitol 
Sodium Benzoate 
Anhydrous citric acid 
FD&C Red no. 40 
Water 
saccharin sodium dihydrate 
Propylene glycol 
PRUNUS SEROTINA BARK 
POLYETHYLENE GLYCOL 1450 
D&C RED NO. 33 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-1985-00118 mL in 1 BOTTLE
2NDC:0904-1985-20118 mL in 1 BOTTLE
3NDC:0904-1985-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34308/20/2012
Labeler - Major (191427277)

Revised: 08/2012
 
Major

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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