Label: CHILDRENS SILFEDRINE - pseudoephedrine hydrochloride liquid

  • NDC Code(s): 54838-104-40, 54838-104-70
  • Packager: Silarx Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

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  • ACTIVE INGREDIENT

    Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL(teaspoonful)(TSP))

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  • PURPOSE

    Purpose: Nasal decongestant

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  • INDICATIONS & USAGE

    Uses temporarily relieves nasal congestion due to

    • common cold
    • hay fever
    • other upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
    • promotes nasal and/or sinus drainage
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  • Warnings

    DO NOT USE IN CHILDREN UNDER 4 YEARS OF AGE

    • Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart diseases
    • high blood pressure
    • thyroid disease
    • diabetes

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or accompanied by fever

    Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away (1800-222-1222).

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  • Directions

    • Do not exceed 4 doses in 24 hours.
    • Repeat dose every 4 hours if needed.
    Children 6 to 11 years of age
    2 teaspoonfuls (TSP)
    Children 4 to 5 years of age
    1 teaspoonful(TSP)
    Children under 4 years of age DO NOT USE

    Other information

    store at room temperature

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  • Inactive ingredients

    citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

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  • Questions

    888-974-5279

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:

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

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS SILFEDRINE 
    pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-104
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride 15 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    FD&C blue no. 1  
    FD&C red no. 40  
    glycerin  
    saccharin sodium dihydrate  
    sodium benzoate  
    sodium citrate  
    sorbitol  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-104-40 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:54838-104-70 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/05/2001
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
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