drug facts

drug facts
SPL v2
SPL
SPL Set ID 33bee4db-d4aa-4c72-8eeb-46ff374a92a6
Route
oral
Published
Effective Date 2024-01-12
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 2024-02-01

Purpose

Antigas

Description

Simethicone 180 mg


Medication Information

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 15-30º C (59-86º F)
  • protect from heat and moisture
Inactive Ingredients

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

Description

Simethicone 180 mg

Principal Display Panel

†Compare to Phazyme® Ultra Strength active ingredient

ULTRA STRENGTH

Anti-Gas

simethicone, 180 mg

Antiflatulent

Fast relief of:

  • bloating
  • pressure
  • discomfort
  • gas

softgels

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

Distributed By AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

Use
  • relieves bloating, pressure, or fullness commonly referred to as gas
Product Label
GOOD NEIGHBOR PHARMACY 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

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 15-30º C (59-86º F)
  • protect from heat and moisture
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

†Compare to Phazyme® Ultra Strength active ingredient

ULTRA STRENGTH

Anti-Gas

simethicone, 180 mg

Antiflatulent

Fast relief of:

  • bloating
  • pressure
  • discomfort
  • gas

softgels

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

Distributed By AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

Use
  • relieves bloating, pressure, or fullness commonly referred to as gas
Product Label
GOOD NEIGHBOR PHARMACY 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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