Label: DOLOFIN INFANTIL- 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 September 12, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Acetaminophen 160 mg

  • PURPOSE

    Purpose

    Acetaminophen.............................Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    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.

  • ASK DOCTOR

    Ask a doctor before use if your child has

    liver disease.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

  • WHEN USING

    When using this product

    • do not exceed recommended dose
    (see overdose warning)

  • STOP USE

    Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

    Overdose Warning: Taking more than the
    recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
    professional assistance or contact a Poison Control
    Center immediately. Quick medical attention is
    critical even if you do not notice any signs or
    symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • this product does not contain directions or
    complete warnings for adult use.
    • shake well before using
    • find right dose on chart below. If possible, use
    weight to dose; otherwise, use age.
    • use only enclosed dosing cup designed for use
    with this product. Do not use any other dosing
    device.
    • if needed, repeat dose every 4 hours while
    symptoms last
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed
    by a doctor

    Weight (lb) Age (yr) Dose (tsp or mL)
    under 24          under 2              ask a doctor
    24-35                2-3             1 teaspoon or 5 mL
    36-47                4-5          1 1/2 teaspoons or 7.5 mL
    48-59                6-8           2 teaspoons or 10 mL
    60-71               9-10         2 1/2 teaspoons or 12.5 mL
    72-95                 11            3 teaspoons or 15 mL

  • OTHER SAFETY INFORMATION

    Other information

    • store at controlled room temperature
    • see bottom panel for lot number and
    expiration date

  • INACTIVE INGREDIENT

    Inactive Ingredients

    acesulfame potassium, butyl paraben,
    carboxymethylcellulose sodium, cellulose, citric acid,
    flavors, glycerin, high fructose corn syrup, propylene
    glycol, purified water, red 40, sodium benzoate,
    sorbitol, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Dolofin Infantil Label

  • INGREDIENTS AND APPEARANCE
    DOLOFIN INFANTIL 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-053
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-053-031 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/21/2012
    Labeler - Menper Distributors, Inc. (101947166)