MAPAP INFANTS CONCENTRATED (ACETAMINOPHEN) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]

MAPAP INFANTS CONCENTRATED (ACETAMINOPHEN) SUSPENSION/ DROPS [REBEL DISTRIBUTORS CORP]
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NDC 21695-267-15
Set ID 1df75cdf-dc04-41f8-846e-77ce9ab24548
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each 0.8 mL)

    Acetaminophen 80 mg

  • Purpose

    Fever reducer/pain reliever

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
    • the common 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 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 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 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 lasts more than 5 days
    • fever gets worse or lasts 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.

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

  • Directions

    • do not give more than directed (see Liver warning)
    • shake well before using
    • find right dose on chart. If possible, use weight to dose; otherwise use age.
    • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
    • 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 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
    • replace dropper tightly to maintain child resistance
    • this product does not contain directions or complete warnings for adult use
    Dosing Chart
    Weight(lb) Age(yr)Dose (mL)
    under 24under 2 years ask a doctor
    24-352–3 years 1.6 mL (0.8 + 0.8 mL)

    Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • store at 20°-25°C (68°-77°F)
    • do not use if printed bottle wrap is broken or missing
  • Inactive ingredients

    anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

  • Questions or comments?

    1-800-616-2471

  • Principal Display Panel

    Mapap 80mg/0.8ml

  • INGREDIENTS AND APPEARANCE
    MAPAP  INFANTS CONCENTRATED
    acetaminophen suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-267(NDC:0904-5255)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (opaque) Score    
    ShapeSize
    FlavorCHERRY (sweet) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-267-151 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/15/1990
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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