Label: INFANTS SILAPAP - acetaminophen solution/ drops

  • NDC Code(s): 54838-145-15, 54838-145-30
  • Packager: Silarx Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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

  • ACTIVE INGREDIENT

    Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

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  • PURPOSE

    Purpose: Fever reducer/pain reliever

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  • Uses

    temporarily:

    ■ reduces fever

    ■ relieves minor aches and pains due to:
       ■the common cold ■flu ■toothaches ■sore throat ■headaches 

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  • 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.

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  • Do not use

    • with any other product 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.

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  • When using this product

    • do not exceed recommended dosage. (see overdose warning)
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  • 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 serious condition.


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  • KEEP OUT OF REACH OF CHILDREN

    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, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    this product does not contain directions or complete warnings for adult use
    do not give more than directed (see overdose warning)
    ■ find right dose on chart, if possible use weight to dose; otherwise, use age
    ■ use only enclosed dropper designed for use with this product, do not use any other dosing device
    ■ fill to dose level
    ■ dispense liquid slowly into child's mouth, toward inner cheek
    ■ may be given alone or mixed with formula, milk, juice etc.
    ■ If needed, repeat dose every 4 hours
    ■ do not give more than 5 times in 24 hours
    ■ Replace dropper tightly to maintain child resistance

    Weight (lb) Age (yr)
    Dose (mL)
    under 24
    under 2 years
    ask a doctor
    24-35
    2-3 years
     1.6 mL (0.8 + 0.8 mL)

    For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb.

    Other information
    Store between 20° - 25°C (68° - 77°F)

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  • Inactive ingredients

    citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

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  • Comments

    1-888-974-5279

    Manufactured by:

    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave.
    Carmel , NY 10512

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  • INGREDIENTS AND APPEARANCE
    INFANTS SILAPAP 
    acetaminophen solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-145
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    FD&C yellow no. 6  
    methylparaben  
    saccharin sodium dihydrate  
    sodium benzoate  
    sodium citrate  
    propylene glycol  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (wild cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-145-15 15 mL in 1 BOTTLE, DROPPER
    2 NDC:54838-145-30 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/01/1997
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
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