CHILDRENS MAPAP ACETAMINOPHEN- acetaminophen liquid 
ATLANTIC BIOLOGICALS CORP.

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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Childrens MĀPAP Acetaminophen Liquid ®

Active ingredient (in each TSP (5 mL))

Acetaminophen 160 mg

Purpose

Fever reducer-Pain reliever

Uses

Temporarily relieves minor aches and pains due to:

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

liver disease Ask a doctor before use if your child has

taking the blood thinning drug warfarin. Ask a doctor or pharmacist before use if your child is

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.

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

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

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

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

CHILDRENS MAPAP ACETAMINOPHEN (ACETAMINOPHEN) LIQUID

image description

CHILDRENS MAPAP ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1984(NDC:0904-1985)
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
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Anhydrous citric acid (UNII: XF417D3PSL)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Water (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Propylene glycol (UNII: 6DC9Q167V3)  
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-1984-22 mL in 1 SYRINGE; Type 0: Not a Combination Product01/28/2021
2NDC:17856-1984-45 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product01/28/2021
3NDC:17856-1984-33.75 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
4NDC:17856-1984-33.75 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/20/2012
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707RELABEL(17856-1984) , REPACK(17856-1984)

Revised: 1/2021
Document Id: eb94ee3a-01ff-44f9-96c4-3e5e996da82d
Set id: c8a22286-6ace-4c51-873a-4867d3934fd4
Version: 9
Effective Time: 20210128
 
ATLANTIC BIOLOGICALS CORP.