Label: FIRSTCARE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 MG ANTI-GAS- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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  • Active ingredient (in each chewable)

    Simethicone, 250 mg

  • Purpose

    Antigas

  • Uses

    for the relief of

    • pressure, bloating, and fullness commonly referred to as gas
  • WARNINGS

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

  • Directions

    • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
    • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.
  • Other information

    • each chewable contains  sodium 5 mg. very low sodium
    • store at controlled room temperature 20-25°C (68-77°F).
    • protect from light, heat and moisture.
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.
  • Inactive ingredients:

    carnauba wax, citric acid, croscarmellose sodium, crospovidone, FD&C red #40, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

  • Questions or comments?

    Call 1-800-227-6151

  • SPL UNCLASSIFIED SECTION

    USpharma

    13900 NW 57th Court, Miami Lakes, FL 33014

    1-800-227-6151 www.uspharmaltd.com

  • Principal display Panel-250 mg bottle label

    FIRSTCARE

    MADE IN USA

    NDC 71594-707-08

    MAXIMUM STRENGTH

    GAS RELIEF

    SIMETHICONE 250 mg

    Anti-gas

    Fast Relief of:

    Bloating, Pressure,
    Gas discomfort

    Mixed Berry Flavor

    20 SOFT CHEWABLES

    Principal display Panel-250 mg bottle label

  • INGREDIENTS AND APPEARANCE
    FIRSTCARE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 MG ANTI-GAS 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACACIA (UNII: 5C5403N26O)  
    MALTITOL (UNII: D65DG142WK)  
    MANNITOL (UNII: 3OWL53L36A)  
    MILK PROTEIN CONCENTRATE (UNII: 871QYF3I7B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeSQUARESize15mm
    FlavorBERRY (MIXED BERRY) Imprint Code 7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71594-707-0820 in 1 BOTTLE; Type 0: Not a Combination Product07/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00207/04/2023
    Labeler - USpharma Ltd (080664601)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(71594-707)
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