INFANTS MAPAP PAIN RELIEVER /FEVER REDUCER- acetaminophen solution/ drops 
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.

----------

INFANTS' MAPAP®
Pain Reliever /Fever Reducer

Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Pain reliever / fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
cold
flu
headache
sore throat
toothache

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 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 dose (see overdose warning)

Stop use and ask a doctor if

pain gets worse or lasts 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.

Keep out of reach of children

Overdose warning

Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

USE A DOSING DEVICE to give this medicine
use weight, if possible, to dose; otherwise use age
Fill to dose level.
Dispense liquid slowly into child's mouth, toward inner cheek.
if needed, repeat dose every 4 hours while symptoms last.
do not give more than 5 doses in 24 hours
Children 2 to 3 years or 24 to 35 pounds: 2 dropperfuls (2 x 0.8 mL).
Children under 2 years or under 24 pounds: ask a doctor

Other Information

TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.
keep tightly closed
store at room temperature

Inactive Ingredients

artificial fruit flavor, artificial orange flavor, butylparaben, citric acid, FD&C Yellow #6, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin, sodium citrate.

Questions?

Adverse Drug Event Call
(800) 616-2471

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC 0904-5901-35

MAJOR®

INFANTS'

TAMPER-EVIDENT

Māpap®

(acetaminophen 80 mg per 0.8 mL)

PAIN RELIEVER/
FEVER REDUCER

FRUIT FLAVOR

Fast, Effective Relief
of Infants' Fever
and Pain

ALCOHOL-FREE
ASPIRIN-FREE
IBUPROFEN-FREE

1/2 FL OZ (15 mL)

Compare to active ingredient of
Infants' TYLENOL® Drops*

Principal Display Panel - 15 mL Bottle Carton
INFANTS MAPAP  PAIN RELIEVER /FEVER REDUCER
acetaminophen solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Saccharin (UNII: FST467XS7D)  
Butylparaben (UNII: 3QPI1U3FV8)  
FD&C Yellow no. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorFRUIT, ORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5901-3515 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/201206/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/24/201206/20/2016
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)

Revised: 2/2018
 
Major Pharmaceuticals