Label: EXTRA STRENGTH GAS RELIEF- simethicone liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 20, 2023

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  • Active Ingredient (in each 5 mL)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for the relief of pressure, bloating, and fullness commonly referred to as gas

  • Warnings

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    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
    ▪
    do not take more than 20 mL in any 24-hour period except under the advice and supervision of a physician
    ▪
    measure only with dosing cup provided
    ▪
    do not use dosing cup with other products
    ▪
    mL = milliliter
    ▪
    adults: 5 mL or 10 mL in dosing cup provided as needed after meals and at bedtime.
  • Other information

    ▪
    Each 5 mL contains: sodium 2 mg
    ▪
    store at 20° – 25°C (68° – 77°F )
    ▪
    do not refrigerate
    ▪
    protect from light, heat, and moisture
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid anhydrous, flavor, glycerin, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

    Call 1-800-824-4894

  • Principal Display Panel

    SAFE AND EFFECTIVE RELIEF

    RELIEVES GAS FAST

    NDC# 55505-225-36

    Kaopectate®

    Simethicone 125mg Anti-gas

    Extra Strength

    Gas Relief Liquid

    ✓
    Pressure
    ✓
    Bloating
    ✓
    Discomfort

    Starts to work in minutes

    •
    Dye-free
    •
    Sugar-free

    Berry Flavor

    48 DOSES

    Dosage cup inside

    8 FL OZ (237 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by

    Kramer Laboratories, Inc.,

    Bridgewater, NJ, 08807

    1-800-824-4894

    TAMPER EVIDENT: Do not use if foil seal under cap, printed with “SEALED FOR YOUR PROTECTION” is missing, open or broken.

    Kaopectate Extra Strength Gas Relief Liquid Berry Flavor
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH  GAS RELIEF
    simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-225-36237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00208/26/2020
    Labeler - KRAMER LABORATORIES (122720675)
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