INFANTS MAPAP- acetaminophen suspension 
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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Infants' MĀPAP® Suspension Liquid

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

•
headache
•
common cold
•
flu
•
toothache
•
sore throat

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, lasts for more than 2 days or 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.

Ask a doctor before use if the 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.

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
•
redness or swelling is present
•
any new symptoms appear

These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

•
this product does not contain directions or complete warnings for adult use
•
shake well before using
•
if possible, use weight to dose; otherwise use age
•
use only with enclosed syringe. Do not use with any other dosing device
•
push air out of syringe. Firmly push syringe into bottle opening.
•
turn bottle upside-down and pull syringe to the correct dose
•
dispense liquid slowly into child's mouth, towards inner cheek
•
give dose every 4 hours while symptoms last
•
do not give more than 5 doses in 24 hours

24-35 lbs (2-3 years); 5 mL

Under 24 lbs (under 2 years); ask a doctor

Other information

store at 20°-25° C (68°-77° F)

Inactive ingredients

Artificial flavor, citric acid anhydrous, corn syrup, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

Call 1-800-616-2471

DISTRIBUTED BY: MAJOR® PHARMACEUTICALS
31778 Enterprise Drive Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

NDC 0904-6307-03

MAJOR®

INFANTS'

FEVER REDUCER – PAIN RELIEVER
Māpap®

ACETAMINOPHEN ORAL SUSPENSION

Fast, Effective Relief of
Infant's Fever and Pain

Dye Free

• Alcohol Free • Ibuprofen Free
• Aspirin Free • Cherry Flavor

READ THE LABEL

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

2 FL OZ (59 ML)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
INFANTS MAPAP 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate (UNII: OJ245FE5EU)  
Sorbitol (UNII: 506T60A25R)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene glycol (UNII: 6DC9Q167V3)  
Xanthan gum (UNII: TTV12P4NEE)  
Corn Syrup (UNII: 9G5L16BK6N)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Prunus Serotina Bark (UNII: 5D48E975HA)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
Sucralose (UNII: 96K6UQ3ZD4)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6307-031 in 1 CARTON06/01/201205/12/2016
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/201205/12/2016
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(0904-6307) , ANALYSIS(0904-6307) , PACK(0904-6307) , LABEL(0904-6307)

Revised: 7/2018
Document Id: 00994f48-f52d-42cb-8b30-c532c90217f8
Set id: dbbeeebc-48c3-42b2-ac08-aadfe43cfede
Version: 2
Effective Time: 20180724
 
Major Pharmaceuticals