drug facts

drug facts
SPL v4
SPL
SPL Set ID aa074ceb-b86e-4a07-b885-b8fa6c1e0fcf
Route
oral
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (180 mg)
Inactive Ingredients
fd&c yellow no. 6 gelatin glycerin water fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Imprint: S180;05A Shape: capsule Color: orange Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-12-31

Purpose

Antiflatulent (Antigas)

Description

Simethicone 180 mg


Medication Information

Uses
  • relieves bloating, pressure, or fullness commonly referred to as gas
Purpose

Antiflatulent (Antigas)

Directions
  • swallow one or two softgels as needed after meals
  • do not exceed two softgels per day except under the advice and supervision of a physician
Other Information
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients

FD&C red #40*, FD&C yellow #6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

Description

Simethicone 180 mg

Principal Display Panel

Compare to Phazyme® Ultra Strength active ingredient††

Gas Relief 

SIMETHICONE 180 mg / ANTI-GAS

ULTRA STRENGTH

SOFTGELS

  • Relieves bloating, gas, pressure & discomfort

SOFTGELS

EASY-TO-SWALLOW SOFTGELS

††This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Product Label
WALGREENS Gas Relief
Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If

condition persists.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 180 mg


Structured Label Content

Uses
  • relieves bloating, pressure, or fullness commonly referred to as gas
Purpose

Antiflatulent (Antigas)

Directions
  • swallow one or two softgels as needed after meals
  • do not exceed two softgels per day except under the advice and supervision of a physician
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients (Inactive ingredients)

FD&C red #40*, FD&C yellow #6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

Principal Display Panel

Compare to Phazyme® Ultra Strength active ingredient††

Gas Relief 

SIMETHICONE 180 mg / ANTI-GAS

ULTRA STRENGTH

SOFTGELS

  • Relieves bloating, gas, pressure & discomfort

SOFTGELS

EASY-TO-SWALLOW SOFTGELS

††This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Product Label
WALGREENS Gas Relief
Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 180 mg


Advanced Ingredient Data


Raw Label Data

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