Quality Choice 44-608

Quality Choice 44-608
SPL v2
SPL
SPL Set ID c04422ce-779f-416a-aebf-4ccdfeaaae87
Route
ORAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Starch, Corn Sucralose Tribasic Calcium Phosphate Dimethicone 410

Identifiers & Packaging

Pill Appearance
Imprint: 44;608 Shape: round Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-07

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Directions
  • do not take more than directed

  • chew or crush tablets completely before swallowing; do not swallow tablets whole

  • adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime

  • do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information
  • each tablet contains: calcium 85 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 83324-325-18

Extra Strength

Gas

Relief

Simethicone 125 mg

Chewable Tablets

Antigas

Relieves:

Pressure

Bloating

Discomfort

Cherry Flavored

Do not swallow

tablets whole.

Chew or crush tablets

completely

before swallowing.

Actual Size

*This product is not manufactured or distributed by Haleon CH SARL, owner of

the registered trademark Gas-X® Extra Strength. 50844 ORG122060844

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

• SATISFACTION

100%

QC®

GUARANTEED

Quality Choice 44-608

 

 

Active Ingredient (in Each Chewable Tablet)

Simethicone 125 mg


Structured Label Content

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Purpose

Antigas

Directions
  • do not take more than directed

  • chew or crush tablets completely before swallowing; do not swallow tablets whole

  • adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime

  • do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information (Other information)
  • each tablet contains: calcium 85 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 83324-325-18

Extra Strength

Gas

Relief

Simethicone 125 mg

Chewable Tablets

Antigas

Relieves:

Pressure

Bloating

Discomfort

Cherry Flavored

Do not swallow

tablets whole.

Chew or crush tablets

completely

before swallowing.

Actual Size

*This product is not manufactured or distributed by Haleon CH SARL, owner of

the registered trademark Gas-X® Extra Strength. 50844 ORG122060844

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

• SATISFACTION

100%

QC®

GUARANTEED

Quality Choice 44-608

 

 

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)