ms gas relief - simethicone 250mg

ms gas relief - simethicone 250mg
SPL v1
SPL
SPL Set ID b21b92f4-5889-ac05-e053-2a95a90ade4f
Route
oral
Published
Effective Date 2020-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (250 mg)
Inactive Ingredients
water fd&c blue no. 1 sorbitol d&c red no. 33 glycerin povidone gelatin

Identifiers & Packaging

Pill Appearance
Imprint: 788 Shape: oval Color: purple Size: 13 mm Score: 1
Marketing Status
otc monograph final active Since 2020-10-20
Description

Simethicone 250mg

Medication Information

Warnings and Precautions

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Active Ingredient

Simethicone 250mg

Indications and Usage

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and Administration

  • swallow one or two softgels as symptoms occur
  • do not exceed 2 softgels per 24 hours except under the advice and super vision of a physician

Description

Simethicone 250mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol

Section 51945-4

Section 55105-1

Anti-gas

Section 60561-8
  • store at room temperature between 20-25°C (68-77ºF).
  • protect from heat, humidity and light.
  • TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

Structured Label Content

Warnings and Precautions (34071-1)

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Active Ingredient (55106-9)

Simethicone 250mg

Indications and Usage (34067-9)

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and Administration (34068-7)

  • swallow one or two softgels as symptoms occur
  • do not exceed 2 softgels per 24 hours except under the advice and super vision of a physician

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-gas

Section 60561-8 (60561-8)
  • store at room temperature between 20-25°C (68-77ºF).
  • protect from heat, humidity and light.
  • TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:56.469171 · Updated: 2026-03-14T22:58:44.558202