SPL v1
SPL
SPL Set ID 20935a7f-41dd-93c5-e063-6294a90aa1c4
Route
ORAL
Published
Effective Date 2024-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (180 mg)
Inactive Ingredients
Water Glycerin Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: orange Size: 10 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-26

Description

Simethicone 180 mg

Purpose

Anti-gas


Medication Information

Purpose

Anti-gas

Description

Simethicone 180 mg

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Section 51945-4

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Directions

swallow one or two softgels as needed after a meal

do not exceed two softgels per day except under the advice and supervision of a physician

Other Information

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Keep Out of Reach of Children

Keep out of reach of children.

Active Ingredient (in Each Capsule)

Simethicone 180 mg


Structured Label Content

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Section 51945-4 (51945-4)

Purpose

Anti-gas

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Directions

swallow one or two softgels as needed after a meal

do not exceed two softgels per day except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients (Inactive ingredients)

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

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

Keep out of reach of children.

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

Simethicone 180 mg


Advanced Ingredient Data


Raw Label Data

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