drug facts

drug facts
SPL v2
SPL
SPL Set ID 011859d8-3d0f-4ca7-a98b-4150054154dc
Route
oral
Published
Effective Date 2024-08-02
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 fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Imprint: 05A Shape: capsule Color: orange Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-11-30

Purpose

Antiflatulent (Antigas)

Description

Simethicone 180 mg


Medication Information

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

Antiflatulent (Antigas)

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

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Description

Simethicone 180 mg

Principal Display Panel

Compare to Phazyme® Ultra Strength active ingredient†

Ultra Strength

Gas Relief

simethicone 180 mg (antigas)

fast relief of:

  • gas
  • pressure
  • bloating
  • discomfort

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 UNFI

PROVIDENCE, RI 02908

Product Label
EQUALINE Ultra Strength Gas Relief
Questions Or Comments?

Call toll free 1-855-423-2630

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

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Principal Display Panel

Compare to Phazyme® Ultra Strength active ingredient†

Ultra Strength

Gas Relief

simethicone 180 mg (antigas)

fast relief of:

  • gas
  • pressure
  • bloating
  • discomfort

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 UNFI

PROVIDENCE, RI 02908

Product Label
EQUALINE Ultra Strength Gas Relief
Questions Or Comments? (Questions or comments?)

Call toll free 1-855-423-2630

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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