Label: EXTRA STRENGTH GAS RELIEF- simethicone liquid

  • NDC Code(s): 68163-700-08
  • Packager: Raritan Pharmaceuticals Inc
  • 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 September 18, 2020

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

  • 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.
    do not exceed 4 softgels in 24 hours unless directed by a doctor
  • Other information

    store at room temperature
    do not refrigerate
    protect from light, heat, and moisture
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-866-467-2748

  • Principal Display Panel

    SAFE AND EFFECTIVE RELIEF

    NuRelief

    NDC# 68163-700-08

    Relieves Gas, Bloating & Abdominal Discomfort

    EXTRA STRENGTH

    Gas relief liquid

    Simethicone 125mg/Anti-Gas

    FAST RELIEF

    Relives Gas, bloating & Abdominal Discomfort

    DYE & SUGAR FREE

    Tropical Fruit Flavor

    Naturally Flavored

    48 DOSES

    Dosage cup Included

    8 FL OZ (237 mL)

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

    Distributed by Lifelab Health LLC

    5300 W Hillsboro Blvd, Suite 202

    Coconut Creek, FL 33073

    www.NuRelief.com

    MADE IN USA

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    NuRelief Gas Relief Liquid Tropical Fruit
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH  GAS RELIEF
    simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-700
    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 FORM (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
    Color    Score    
    ShapeSize
    FlavorTROPICAL FRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-700-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/26/2020
    Labeler - Raritan Pharmaceuticals Inc (127602287)