Home > Drugs A-Z > Infants Pain Reliever

Infants Pain Reliever (Rij Pharmaceutical Corporation)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE, PLASTIC in 1 CARTON (53807-220-05) > 15 mL in 1 BOTTLE, PLASTIC Label Information

Complete Infants Pain Reliever Information

  • Active ingredient (in each 1.6 mL = 2 droppersful)

    Acetaminophen 160 mg


  • Purpose

    Fever reducer/ pain reliever


  • 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 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 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; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

    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.
    • fill to dose level. Do not use any other dosing device.
    • dispense liquid slowly into child's mouth, toward inner cheek.
    • if needed, repeat dose every 4 hours while symptoms last.
    • do not give use than 5 times in 24 hours
    • replace original bottle cap to maintain child resistance
    • use only with enclosed dropper
    • rinse dropper after each use

    Dosing Chart

    Weight (lbs.) Age (yrs.) Dose ( mL)
    under 24 under 2 ask a doctor
    24-35 2-3 2 droppersful (0.8 + 0.8 mL)

    Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.


  • Other information

    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
    • shake well before use.
    • Store at room Temperature 15º - 30ºC (59º - 86ºF)
    • protect from freezing.

  • Inactive ingredients

    butyl paraben, cellulose, citric acid, FD&C Blue # 1 FD&C Red # 33, glycerin, high fructose corn syrup, propylene glycol, sodium benzoate, sorbitol, water, xanthan gum


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel


  • INGREDIENTS AND APPEARANCE
    INFANTS PAIN RELIEVER 
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-220
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg  in 1.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53807-220-05 1 in 1 CARTON 03/16/1999
    1 15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    Name Address ID/FEI Business Operations
    Rij Pharmaceutical Corporation 144679156 manufacture(53807-220)