DULCOGAS- simethicone tablet, chewable

DulcoGas by

Drug Labeling and Warnings

DulcoGas by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient (in each tablet): Purpose
• Simethicone (USP) 125 mg: Antigas

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

PRINCIPAL DISPLAY PANEL

DulcoGas Tangy Citrus Simethicone 125 mg

PRINCIPAL DISPLAY PANEL

DulcoGas Tropical Simethicone 125 mg

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)