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Infants Relief (CVS)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, DROPPER in 1 CARTON (59779-102-05) > 15 mL in 1 BOTTLE, DROPPER Label Information

Complete Infants Relief Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg


  • Purpose

    Anti-gas


  • Uses

    Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.


  • Warnings

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


  • Directions

    • shake well before using
    • all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day
    • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
    • dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids
    • for best results, clean dropper after each use and replace original cap
    Age (yr) Weight (lb) Dose
    infants under 2 under 24 0.3 mL
    children over 2 over 24 0.6 mL

  • Other information

    • do not use if printed foil seal under cap is torn or missing
    • store at room temperature
    • do not freeze
    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose


  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS/pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895


  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    CVS®
    pharmacy

    Compare to the
    active ingredient in
    Infants' MYLICON
    ® Drops*

    Infants'
    GAS
    RELIEF
    NON-STAINING FORMULA

    SIMETHICONE/ANTIGAS

    No alcohol
    No saccharin
    No artificial
    flavor

    50 Doses
    0.5 FL OZ (15 mL)

    Principal Display Panel - 15 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    INFANTS RELIEF   NON-STAINING FORMULA
    dimethicone 410 liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-102
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone 410 (UNII: TYU5GP6XGE) (Dimethicone 410 - UNII:TYU5GP6XGE) Dimethicone 410 20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Vanillin (UNII: CHI530446X)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor VANILLA, STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-102-05 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 02/03/2012
    Labeler - CVS (062312574)
    Registrant - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    Name Address ID/FEI Business Operations
    davAgen Pharmaceutical, LLC 967545935 MANUFACTURE, PACK, LABEL, ANALYSIS