660r - Target Simethicone 125 Mg Chewable Tablets - Cherry Flavor

660r - Target Simethicone 125 Mg Chewable Tablets - Cherry Flavor
SPL v2
SPL
SPL Set ID 290fe08d-a0b9-82f7-e063-6394a90a9c75
Route
ORAL
Published
Effective Date 2025-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Guar Gum Silicon Dioxide Acacia Sorbitol Silicified Microcrystalline Cellulose (65 ?m) Sodium Stearyl Fumarate D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Tribasic Calcium Phosphate Fd&c Red No. 40 Aluminum Lake Sucralose Sucrose Magnesium Stearate Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: 165 Shape: round Color: pink Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-29

Description

Drug Facts


Medication Information

Warnings and Precautions

Warning

Indications and Usage

Use for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Dosage and Administration

Directions

  • adults and children 12 years and older: chew 1 or 2 tablets as needed after meals and at bedtime. Chew or crush tablets completely before swallowing.
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
Description

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

acacia, D&C red no. 30 aluminum lake, dextrose monohydrate, FD&C red no. 40 aluminum lake, flavors, guar gum, magnesium stearate, maltodextrin, silicified microcrystalline cellulose, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sucrose, tribasic calcium phosphate

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 55105-1

Purpose

Antigas

Section 55106-9

Active ingredient (in each tablet)

Simethicone 125 mg

Section 60561-8

Other information

  • Store at controlled room temperature 20-25°C (68-77 °F).
  • Protect from moisture
Drug Facts

Drug Facts


Structured Label Content

Indications and Usage (34067-9)

Use for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and older: chew 1 or 2 tablets as needed after meals and at bedtime. Chew or crush tablets completely before swallowing.
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
Warnings and Precautions (34071-1)

Warning

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

acacia, D&C red no. 30 aluminum lake, dextrose monohydrate, FD&C red no. 40 aluminum lake, flavors, guar gum, magnesium stearate, maltodextrin, silicified microcrystalline cellulose, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sucrose, tribasic calcium phosphate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 55105-1 (55105-1)

Purpose

Antigas

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Simethicone 125 mg

Section 60561-8 (60561-8)

Other information

  • Store at controlled room temperature 20-25°C (68-77 °F).
  • Protect from moisture
Drug Facts

Drug Facts


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)