Label: DULCOGAS- simethicone tablet, chewable

  • NDC Code(s): 0597-0165-36, 0597-0165-37, 0597-0165-88, 0597-0170-37, view more
    0597-0170-88, 0597-0186-88
  • Packager: Boehringer Ingelheim 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 June 2, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts 
    Active ingredient (in each tablet)Purpose
    Simethicone (USP) 125 mgAntigas
  • PURPOSE

  • INDICATIONS & USAGE

    Use 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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults: chew 1 or 2 tablets as needed after meals and at bedtime
    • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
  • OTHER SAFETY INFORMATION

    Other information

    • do not use if individual blister unit is open or torn
    • store at 20-25°C (68-77°F)
    • protect from excessive humidity
  • INACTIVE INGREDIENT

    Wild Berry
    Inactive ingredients D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C blue #1 aluminum lake, flavors, propylene glycol, silicon dioxide, sorbitol, starch, stearic acid, talc, triacetin, tribasic calcium phosphate


    Tangy Citrus
    Inactive ingredients citric acid, D&C yellow #10 aluminum lake, dextrates hydrated, flavors, silicon dioxide, sorbitol, starch, stearic acid, talc, tribasic calcium phosphate


    Sabor Tropical
    Inactive ingredients dextrates hydrated, FD&C yellow #6 aluminum lake, flavors, maltodextrin, medium chain triglycerides, silicon dioxide, sorbitol, starch, stearic acid, talc, tribasic calcium phosphate

  • QUESTIONS

    Questions? call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.DulcoGas.com

    Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. © 2015, BI Pharmaceuticals, Inc. All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    DulcoGas Wild Berry Simethicone 125 mg

    dulcogas-berry-18-ct-carton
  • PRINCIPAL DISPLAY PANEL

    DulcoGas Tangy Citrus Simethicone 125 mg

    dulcogas-citrus-30-ct-carton
  • PRINCIPAL DISPLAY PANEL

    DulcoGas Tropical Simethicone 125 mg

    dulcogas-tropical-18-ct-carton
  • INGREDIENTS AND APPEARANCE
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0170
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTRATES (UNII: G263MI44RU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeROUNDSize14mm
    FlavorCITRUS (Tangy) Imprint Code DULCO;GAS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0170-883 in 1 CARTON02/28/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0170-375 in 1 CARTON02/28/2014
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/28/2014
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DEXTRATES (UNII: G263MI44RU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUNDSize14mm
    FlavorBERRY (Wild) Imprint Code DULCO;GAS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0165-883 in 1 CARTON02/28/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0597-0165-375 in 1 CARTON02/28/2014
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0597-0165-361 in 1 CARTON02/28/201411/30/2015
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/28/2014
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize14mm
    FlavorTROPICAL FRUIT PUNCHImprint Code DULCO;GAS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0597-0186-883 in 1 CARTON04/10/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/10/2014
    Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)