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 mg Antigas
    Close
  • 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.

    Close
  • 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
    Close
  • 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
    Close
  • 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

    Close
  • 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.

    Close
  • PRINCIPAL DISPLAY PANEL

    DulcoGas Wild Berry Simethicone 125 mg

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

    DulcoGas Tangy Citrus Simethicone 125 mg

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

    DulcoGas Tropical Simethicone 125 mg

    dulcogas-tropical-18-ct-carton
    Close
  • INGREDIENTS AND APPEARANCE
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0170
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color YELLOW Score 2 pieces
    Shape ROUND Size 14mm
    Flavor CITRUS (Tangy) Imprint Code DULCO;GAS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0597-0170-88 3 in 1 CARTON 02/28/2014
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0597-0170-37 5 in 1 CARTON 02/28/2014
    2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 02/28/2014
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0165
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color PURPLE Score 2 pieces
    Shape ROUND Size 14mm
    Flavor BERRY (Wild) Imprint Code DULCO;GAS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0597-0165-88 3 in 1 CARTON 02/28/2014
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0597-0165-37 5 in 1 CARTON 02/28/2014
    2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0597-0165-36 1 in 1 CARTON 02/28/2014 11/30/2015
    3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 02/28/2014
    DULCOGAS 
    simethicone tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0186
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color ORANGE Score 2 pieces
    Shape ROUND Size 14mm
    Flavor TROPICAL FRUIT PUNCH Imprint Code DULCO;GAS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0597-0186-88 3 in 1 CARTON 04/10/2014
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 04/10/2014
    Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
    Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
    Close