Gas Relief Simethicone, 250 Mg Anti-gas

Gas Relief Simethicone, 250 Mg Anti-gas
SPL v4
SPL
SPL Set ID 63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5
Route
ORAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
Mannitol Milk Protein Concentrate Propylene Glycol Sorbitol Starch, Corn Sucralose Sucrose Carnauba Wax Maltitol Anhydrous Citric Acid Croscarmellose Sodium Crospovidone D&c Red No. 30 Aluminum Lake Corn Syrup Glycerin Acacia

Identifiers & Packaging

Pill Appearance
Imprint: 7 Shape: square Color: red Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-08

Description

Simethicone, 250 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone, 250 mg

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 42229-5

Other information

  • each chewable contains: potassium 5 mg, sodium 5 mg. 

very low sodium

  • store at controlled room temperature 20-25°C (68-77°F).
  • protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.
Warnings

Directions
  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.
Inactive Ingredients:

carnauba wax, citric acid, croscarmellose sodium, crospovidone, D&C red #30 aluminum lake, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

Keep Out of Reach of Children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Active Ingredient (in Each Chewable)

Simethicone, 250 mg

Principal Display Panel 250 Mg Label

CVS Health Compare to the active ingredient in Gas-X ®*

NDC 51316-702-12

Gas Relief

SIMETHICONE, 250 mg

Anti-gas

Fast Relief of:

Bloating,  Pressure &

Gas discomfort



Actual Size    Mixed Berry Flavor

30 SOFT CHEWABLES


Structured Label Content

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 42229-5 (42229-5)

Other information

  • each chewable contains: potassium 5 mg, sodium 5 mg. 

very low sodium

  • store at controlled room temperature 20-25°C (68-77°F).
  • protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.
Purpose

Antigas

Warnings

Directions
  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.
Inactive Ingredients: (Inactive ingredients:)

carnauba wax, citric acid, croscarmellose sodium, crospovidone, D&C red #30 aluminum lake, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

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

Simethicone, 250 mg

Principal Display Panel 250 Mg Label (Principal display Panel-250 mg label)

CVS Health Compare to the active ingredient in Gas-X ®*

NDC 51316-702-12

Gas Relief

SIMETHICONE, 250 mg

Anti-gas

Fast Relief of:

Bloating,  Pressure &

Gas discomfort



Actual Size    Mixed Berry Flavor

30 SOFT CHEWABLES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)