Label: CHILDRENS MAPAP ACETAMINOPHEN- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 1, 2016

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  • 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

    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

    • 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

    • sodium 1mg Each TSP(5 mL) contains:
    • 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

  • CHILDRENS MAPAP ACETAMINOPHEN (ACETAMINOPHEN) LIQUID

    Label Image
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MAPAP ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1986(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:17856-1986-250 in 1 CASE03/01/2016
    115.6 mL in 1 CUP, UNIT-DOSE ; Type 0: Not a Combination Product
    2NDC:17856-1986-350 in 1 CASE03/01/2016
    231.2 mL in 1 CUP, UNIT-DOSE ; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/20/2012
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-1986) , REPACK(17856-1986)
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