Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f4526eba-e6d0-44de-99ea-4af7a6dba199
Route
ORAL
Published
Effective Date 2024-02-14
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

Identifiers & Packaging

Pill Appearance
Imprint: PC3 Shape: capsule Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-31

Description

Simethicone 180 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Use
  • relieves bloating, pressure, or fullness commonly referred to as gas
Directions
  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Product Label
READYinCASE Ultra Strength Gas Relief
Other Information
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Gas Relief

simethicone 180 mg

Antigas

fast relief of:

  • pressure
  • discomfort
  • Bloating
  • gas

Softgels

†This product is not manufactured or distributed by Prestige Consumer Healthcare, 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:

PL Developments

200 Hicks Street

Westbury, NY 11590

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

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

Antigas

Directions
  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Product Label
READYinCASE Ultra Strength Gas Relief
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Gas Relief

simethicone 180 mg

Antigas

fast relief of:

  • pressure
  • discomfort
  • Bloating
  • gas

Softgels

†This product is not manufactured or distributed by Prestige Consumer Healthcare, 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:

PL Developments

200 Hicks Street

Westbury, NY 11590

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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