Label: TEENY TUMMY GAS RELIEF DROPS- simethicone suspension

  • 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 August 14, 2023

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  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

  • Purpose

    Antigas

  • Uses

    relieves the symptoms referred to as gas

  • 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 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. of cool water, infant formula or other suitable liquids
    • clean dropper well after each use and replace original cap on bottle

    Age (years)

    Weight (lbs)

    Dose

    infants under 2

    under 24

    0.3 mL

    children over 2

    over 24

    0.6 mL

  • Other information

    • TAMPER-EVIDENT: Do not use if printed seal under cap is broken or punctured
    • store at room temperature
    • do not freeze
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

    Questions or comments ?

    Call toll-free 1-877-225-6999.

    Manufactured for:

    Akron Pharma, Inc.

    Fairfield, NJ 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TEENY TUMMY  GAS RELIEF DROPS
    simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0041
    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)  
    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
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0041-130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/04/2023
    Labeler - Akron Pharma (067878881)
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