Simethicone Capsules 250 Mg, Liquid Filled

Simethicone Capsules 250 Mg, Liquid Filled
SPL v2
SPL
SPL Set ID 3292fe8e-a41a-4890-baf2-575752704a48
Route
ORAL
Published
Effective Date 2021-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
Gelatin Glycerin Sorbitol Fd&c Blue No. 1 D&c Red No. 33 Povidone K30 Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-03-02
Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Section 50565-1

Keep out of reach of children.

Directions
  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Other Information
  • store at room temperature 59°-86°F (15°-30°C
Inactive Ingredients

gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

Stop Use and Ask A Doctor If

condition persists

Active Ingredient (in Each Capsule)

Simethicone 250 mg

Principal Display Panel Shipping Label

Simethicone capsules

Each Softgel Contains:

(Simethicone 250mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-017-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Structured Label Content

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Directions
  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Other Information
  • store at room temperature 59°-86°F (15°-30°C
Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Simethicone 250 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

Simethicone capsules

Each Softgel Contains:

(Simethicone 250mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-017-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:39.098860 · Updated: 2026-03-14T23:01:06.342894