drug facts

drug facts
SPL v6
SPL
SPL Set ID 24731f4b-ca2b-483f-beed-dfc8104f8133
Route
oral
Published
Effective Date 2025-07-18
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 2020-07-24 Until 2026-10-28

Purpose

Antigas

Description

Simethicone 180 mg


Medication Information

Uses
  • 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
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

Description

Simethicone 180 mg

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Simethicone 180 mg

Antigas

Fast relief of

  • Gas
  • Pressure
  • Bloating
  • Discomfort

†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

Distributed by:

RUGBY® LABORATORIES

Livonia,  MI 48152

www.rugbylaboratories.om

.

Product Label
RUGBY Ultra Strength Gas Relief
Questions Or Comments?

Call 1-800-645-2158

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 symptoms occur
  • do not exceed two softgels per 24 hours 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

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Simethicone 180 mg

Antigas

Fast relief of

  • Gas
  • Pressure
  • Bloating
  • Discomfort

†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

Distributed by:

RUGBY® LABORATORIES

Livonia,  MI 48152

www.rugbylaboratories.om

.

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

Call 1-800-645-2158

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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