Label: INFANTS RELIEF NON-STAINING FORMULA- dimethicone 410 liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 14, 2012

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  • 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 2under 240.3 mL
    children over 2over 240.6 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone 410 (UNII: TYU5GP6XGE) (Dimethicone 410 - UNII:TYU5GP6XGE) Dimethicone 41020 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorVANILLA, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-102-051 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33202/03/2012
    Labeler - CVS (062312574)
    Registrant - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    NameAddressID/FEIBusiness Operations
    davAgen Pharmaceutical, LLC967545935MANUFACTURE, PACK, LABEL, ANALYSIS
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