simethicone 180mg ultra strength gas relief

simethicone 180mg ultra strength gas relief
SPL v1
SPL
SPL Set ID 725f31d8-ce23-4c12-bd2f-f6a14efd155a
Route
oral
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (180 mg)
Inactive Ingredients
fd&c yellow no. 6 gelatin glycerin povidone water sorbitol solution titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-24

Description

Active Ingredients (in each softgel) Simethicone 180 mg


Medication Information

Active Ingredient

Active Ingredients (in each softgel)

Simethicone 180 mg

Indications and Usage

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas
Directions
  • adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Description

Active Ingredients (in each softgel) Simethicone 180 mg

Section 51727-6

D&C yellow #6, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

Section 53413-1

Questions or comments?

Call 1-833-663-2933

Section 55105-1

Purpose

Antigas

Warning
  • Stop use and ask doctor if condition persists.
  • If pregnant or breast-feeding, ask a health professional before use.
Drug Facts

Bottle Label

Keep Out of Reach of Children


Structured Label Content

Active Ingredient (55106-9)

Active Ingredients (in each softgel)

Simethicone 180 mg

Indications and Usage (34067-9)

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas
Directions
  • adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Section 51727-6 (51727-6)

D&C yellow #6, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments?

Call 1-833-663-2933

Section 55105-1 (55105-1)

Purpose

Antigas

Warning
  • Stop use and ask doctor if condition persists.
  • If pregnant or breast-feeding, ask a health professional before use.
Drug Facts

Bottle Label

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


Advanced Ingredient Data


Raw Label Data

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