• 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 December 8, 2011

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


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


    Purpose: Pain reliever/fever reducer


    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


    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

    Repacked by:

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


    Container Label 473 mL

    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-309(NDC:54838-144)
    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
    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    
    FlavorCHERRY (cherry flavor) Imprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-309-04118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/05/1994
    Labeler - H.J. Harkins Company, Inc. (147681894)
    NameAddressID/FEIBusiness Operations
    Silarx Pharmaceuticals, Inc161630033manufacture