Label: MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS- dimethicone solution/ drops

  • 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 October 16, 2019

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

  • Drug Facts

  • Active ingredient (in each 0.3 mL)

    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 sign or symptoms.

  • Directions

    • shake well before using
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • 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.
    • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
    • dosage can also be mixed with 1 oz, cool water, infant formula or other suitable liquids
    • clean dropper well after each use
    • 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 bottom panel for lot number and expiration date
  • Inactive ingredinets

    carboxymethylcellulose sodium, citric acid, ginger extract, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, stevia extract, xanthan gum.

  • Questions?

    Call 1-877-457-4955

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS 
    dimethicone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71444-789
    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 FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GINGER (UNII: C5529G5JPQ)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71444-789-011 in 1 BOX01/05/2020
    130 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 finalpart33201/05/2020
    Labeler - MOM Enterprises, Inc (135903776)