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Pediatric Cough and Cold Medicine (Silarx Pharmaceuticals, Inc)

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LIQUID 120 mL in 1 BOTTLE, PLASTIC (54838-115-40) Label Information

Complete Pediatric Cough and Cold Medicine Information

  • ACTIVE INGREDIENT

    Active Ingredient: Chlorpheniramine maleate 1 mg (in each 5 mL)

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

    Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)


  • PURPOSE

    Purpose of Chlorpheniramine maleate: Antihistamine

    Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

    Purpose of Dextromethorphan hydrobromide: Cough Suppressant


  • INDICATIONS & USAGE

    Uses temporarily relieves common cold, hay fever or other upper respiratory allergy symptoms:

    • nasal congestion
    • runny nose
    • sneezing
    • cough

  • Warnings

    Do not exceed recommended dosage.

    Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if your child has

    • heart diseases
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • asthma
    • a breathing problem or a persistent or chronic cough
    • excessive phlegm (mucus)
    • cough that occurs with too much phlegm (mucus)
    • chronic bronchitis

    Ask a doctor or pharmacist before use if your child is taking sedatives or tranquilizers

    When using this product your child may

    • become easily excited
    • get drowsy
    • sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • Dose may be repeated every 4 to 6 hours or as directed by a doctor
    • Do not exceed 4 doses in 24 - hour period.

     AGE
     DOSE
     Children 6 to under 11 years
     2 teaspoonfuls (TSP)
     Children under 6 years  DO NOT USE

  • Other information

    Store at room temperature 20°-25°C (68°-77°F). Do not use if tamper-evident band around cap is broken or missing.


  • Inactive ingredients

    citric acid, FD&C red no. 40, wild cherry flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol.


  • Questions

    888-974-5279


  • INGREDIENTS AND APPEARANCE
    PEDIATRIC COUGH AND COLD MEDICINE 
    chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (wild cherry flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-115-40 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/05/1997
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/05/1997
    Labeler - Lannett Company, Inc. (161630033)