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

  • 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 May 5, 2023

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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 finalpart33207/04/2023
    Labeler - USpharma Ltd (080664601)
    Establishment
    NameAddressID/FEIBusiness Operations
    USpharma Ltd080664601manufacture(71594-707)
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