Label: CHILDRENS ACETAMINOPHEN- acetaminophen elixir

  • 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 April 30, 2018

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  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • immunizations
      • 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 non-prescription). 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 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

    When using this product do not exceed recommended dose (see overdose warning)

    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.

    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 right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • 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.
    • if needed, repeat dose every 4 hours
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor
    Weight (lbs.)Age (yrs.)Dose (tsp or mL)
    under 24under 2ask a doctor
    24-352-3 years1 tsp or 5 mL
    36-474-5 years1½ tsp or 7.5 mL
    48-596-8 years2 tsp or 10 mL
    60-719-10 years2½ tsp or 12.5 mL
    72-9511 years3 tsp or 15 mL
  • Other information

    •
    Store at room temperature 15º - 30ºC (59º - 86ºF)
    •
    Protect from Freezing.
    •
    Protect from Light.
    •
    each teaspoon (5 mL) contains: sodium 7 mg
    •
    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
  • Inactive ingredients

    citric acid, FD&C red # 40, flavor, glycerin. polyethylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-129
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-129-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-129-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    3NDC:53807-129-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    4NDC:53807-129-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    5NDC:53807-129-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    6NDC:53807-129-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34303/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-129)
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