Label: CVS HEALTH ANTI GAS- simethicone suspension/ drops

  • NDC Code(s): 69842-977-01, 69842-977-15
  • Packager: CVS PHARMACY
  • 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 September 13, 2023

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

  • Active ingredient (in each 0.3 mL)

    Simethicone Emulsion 66.65 mg/Simethicone 20 mg

  • Purpose

    Antigas

  • Uses

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

  • Warnings

    Keep out of reach of children.
    Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    shake well before using
    find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    Only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    remove cap and insert syringe into the bottle.
    pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
    all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
    do not exceed 12 doses per day.
    dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids.
    replace cap tightly to maintain child resistance
    mL = milliliter

    Age (yr)

    Weight (lb)

    Dose (mL)

    infants under 2

    under 24

    0.3

    children over 2

    over 24

    0.6

  • Other information

    tamper evident: do not use if printed seal under cap is broken or missing
    Store at room temperature
    do not freeze
    see carton for full labelling
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, potassium sorbate, purified water, sodium benzoate, , sorbitol, xanthan gum

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    CVS Health®

    Compare to the active ingredient in Infants’ Mylicon® Drops*

    NDC 69842-977-01

    Infants’

    Gas Relief

    SIMETHICONE /ANTI-GAS

    SUPPORTS BABY’S BODY IN RELIEVING GAS†

    Anti-gas

    Safe enough to use at every feeding‡
    Non-staining

    DYE FREE

    Actual Product size on Side Panel

    1 FL OZ (30mL)

    *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops..

    †This medicine in CVS Health® Gas Relief Drops breaks down gas bubbles, helping a baby’s natural process of expelling gas.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    @ 2020 CVS/pharmacy CVS.com®

    1-800-SHOP CVS

    V-12431

    CVS Quality

    Money Back Guarantee

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    Package Label Infants Gas Relief Dye-Free Formula 100 Doses

    Package Label for Infants Gas Relief Dye Free Formula 100 Doses

    Package Label for Infant’s Gas Relief 50 Doses

    Package Label for Infants Gas Relief Dye Free Formula 50 Doses
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ANTI GAS 
    simethicone suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-977
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-977-011 in 1 CARTON04/10/2019
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69842-977-151 in 1 CARTON04/10/2019
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/10/2019
    Labeler - CVS PHARMACY (062312574)