DULCOGAS- simethicone tablet, chewable
Boehringer Ingelheim Pharmaceuticals, Inc.

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.

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Drug Facts
Active ingredient (in each tablet)	Purpose
Simethicone (USP) 125 mg	Antigas

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.

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 information

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

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

DulcoGas Wild Berry Simethicone 125 mg

DulcoGas Tangy Citrus Simethicone 125 mg

DulcoGas Tropical Simethicone 125 mg

DULCOGAS
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0170
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0170-88	3 in 1 CARTON	02/28/2014	10/29/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0170-37	5 in 1 CARTON	02/28/2014	10/29/2021
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/28/2014	10/29/2021

DULCOGAS
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0165
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0165-88	3 in 1 CARTON	02/28/2014	10/29/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0597-0165-37	5 in 1 CARTON	02/28/2014	10/29/2021
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/28/2014	10/29/2021

DULCOGAS
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0597-0186
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0597-0186-88	3 in 1 CARTON	04/10/2014	10/29/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	04/10/2014	10/29/2021

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Revised: 10/2021

Document Id: e526597c-02a4-4c43-a562-72c46c88820b

Set id: 9fbe496c-1aca-8846-5407-56018981c0b4

Version: 5

Effective Time: 20211028

Boehringer Ingelheim Pharmaceuticals, Inc.