DULCOGAS- dimethicone tablet, coated 
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.

----------

Drug Facts 
Active ingredient (in each tablet)Purpose
Simethicone 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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture

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

QUESTIONS?

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

DulcoGas Wild Berry Simethicone 125 mg

DulcoGas Wild Berry

DulcoGas Tangy Citrus Simethicone 125 mg

Tangy Citrus
DULCOGAS 
simethicone tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0597-0170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
ALUMINUM OXIDE 
DEXTRATES 
SILICON DIOXIDE 
SORBITOL 
STARCH, CORN 
STEARIC ACID 
TALC 
TRIBASIC CALCIUM PHOSPHATE 
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 CARTON
16 in 1 BLISTER PACK
2NDC:0597-0170-375 in 1 CARTON
26 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/28/2014
DULCOGAS 
simethicone tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0597-0165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
DEXTRATES 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
SORBITOL 
STARCH, CORN 
TALC 
TRIACETIN 
TRIBASIC CALCIUM PHOSPHATE 
STEARIC ACID 
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 CARTON
16 in 1 BLISTER PACK
2NDC:0597-0165-375 in 1 CARTON
26 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/28/2014
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(0597-0170, 0597-0165)
Establishment
NameAddressID/FEIBusiness Operations
The Dow Chemical Company171862600API MANUFACTURE(0597-0170, 0597-0165)

Revised: 4/2014
 
Boehringer Ingelheim Pharmaceuticals, Inc.