Label: DYE FREE INFANTS PAIN AND FEVER- acetaminophen suspension

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 9, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses temporarily:

    reduces fever
    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

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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

    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.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product
  • 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

    • 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

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Do not take more than directed.

    See overdose warning

    this product does not contain directions or complete warnings for adult use.
    shake well before using

    mL = milliliter
    find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    push air out of syringe. Insert syringe tip into the bottle opening
    flip bottle upside down. Pull yellow part of syringe to correct dose
    dispense liquid slowly into child’s mouth, toward inner cheek
    repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    replace cap tightly to maintain child resistance

    Weight (lbs)Age (yr)Dose (mL)*
    under 24under 2 yearsask a doctor
    24-352-3 years5 mL

    *or as directed by a doctor

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

  • STORAGE AND HANDLING

    Other information

    store between 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

  • QUESTIONS

    Questions or comments?Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    apap-2oz-labelapap-2oz-ifc

  • INGREDIENTS AND APPEARANCE
    DYE FREE INFANTS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7015
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCROSE (UNII: C151H8M554)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7015-041 in 1 BOX04/10/2024
    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 DrugM01304/10/2024
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED677604129manufacture(0363-7015)