Label: CHILDRENS SILAPAP- acetaminophen liquid

  • NDC Code(s): 54838-144-40, 54838-144-70, 54838-144-80
  • Packager: Lannett Company, Inc.
  • 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 June 27, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))

  • PURPOSE

    Purpose: Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses To reduce fever and for the temporary relief of minor aches and pains due to:

    • Headache
    • Muscular aches
    • Backache
    • Minor pain of arthritis
    • The common cold
    • Toothache
    • Premenstrual and menstrual cramps
  • Warnings

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

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • 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 the user consumes 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if the user is allergic to acetaminophen or any of the inactive ingredients in this product

    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
    • These could be signs of a serious condition

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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 (TSP)(5 mL)
     children 4-5 years (36-47 lbs)
     1 1/2 teaspoonfuls (TSP)(7.5 mL)
     children 6-8 years (48-59 lbs)
     2 teaspoonfuls (TSP)(10 mL)
     children 9-10 years (60-71 lbs)
     2 1/2 teaspoonfuls (TSP)(12.5 mL)
     children 11 years (72-95 lbs)
     3 teaspoonfuls (TSP)(15 mL)
     adults & children 12 years & older
     4 teaspoonfuls (TSP)(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
    1033 Stoneleigh Ave.
    Carmel, NY 10512
    USA

  • PRINCIPAL DISPLAY PANEL


    Container Label 237 mL

  • INGREDIENTS AND APPEARANCE
    CHILDRENS SILAPAP 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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    
    ShapeSize
    FlavorCHERRY (cherry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-144-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/1994
    2NDC:54838-144-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/1994
    3NDC:54838-144-80473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34309/05/1994
    Labeler - Lannett Company, Inc. (161630033)