Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cc2dd74a-9cdb-4162-9d05-2b9279f4a38e
Route
ORAL
Published
Effective Date 2025-11-17
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 Completed Since 2020-03-27 Until 2026-12-31
Description

Simethicone 180 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Uses
  • relieves bloating, pressure, or fullness commonly referred to as gas
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
Product Label
WELLNESS BASICS Ultra Strength Gas Relief
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

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

  • 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 BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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

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

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
Product Label
WELLNESS BASICS 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 red #40*, FD&C yellow #6, gelatin, glycerin

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

  • 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 BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:15.281466 · Updated: 2026-03-14T23:10:29.645873