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Acetaminophen (H.J. Harkins Company, Inc.)

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Dosage Form Package Information Links
LIQUID 118 mL in 1 BOTTLE, PLASTIC (52959-309-04) Label Information

Complete Acetaminophen Information

  • ACTIVE INGREDIENT

    Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)


  • PURPOSE

    Purpose: Pain reliever/fever reducer


  • INDICATIONS & USAGE

    Uses temporarily relieves minor aches and pains due to: the common cold

    • flu
    • headache
    • sore throat
    • toothache
    • temporarily reduces fever

  • Warnings

    Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 5 of the recommended doses per day
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

    Do not use

    • with any other product containing acetaminophen.

    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 for more than 5 days
    • fever gets worse or lasts for more than 3 days

    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 of symptoms.


  • Directions

    • do not take more than directed (see overdose warning).
    • if needed, repeat dose every 4 hours or as directed by a doctor
    • do not give more than 5 doses in 24 hours

    children under 2 yrs (under 24 lbs)
    ask a doctor
    children 2-3 years (24-35 lbs)
    1 teaspoonful (5 mL)
    children 4-5 years (36-47 lbs)
    1 1/2 teaspoonfuls (7.5 mL)
    children 6-8 years (48-59 lbs)
    2 teaspoonfuls (10 mL)
    children 9-10 years (60-71 lbs)
    2 1/2 teaspoonfuls (12.5 mL)
    children 11 years (72-95 lbs)
    3 teaspoonfuls (15 mL)
    adults & children 12 years & older
    4 teaspoonfuls (20 mL)
    Other information
    Store at room temperature 20°-25°C (68°-77°F)

  • Inactive ingredients

    citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.


  • Questions

    888-974-5279

    This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.

    Manufactured by:

    Silarx Pharmaceuticals, Inc
    19 West Street
    Spring Valley, NY 10977
    USA

    Repacked by:

    H.J. Harkins Company, Inc.
    513 Sandydale Drive
    Nipomo, CA 93444
    USA


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-309(NDC:54838-144)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (cherry flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52959-309-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/05/1994
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    Name Address ID/FEI Business Operations
    Silarx Pharmaceuticals, Inc 161630033 manufacture