valuhealth by spirit gas relief

valuhealth by spirit gas relief
SPL v3
SPL
SPL Set ID 65da1aec-0d47-4f81-8261-fc5de3231634
Route
oral
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
fd&c blue no. 1 gelatin glycerin peppermint oil sorbitol solution titanium dioxide d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Imprint: 911 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-12-13

Description

Active Ingredients (in each softgel) Simethicone 125 mg


Medication Information

Active Ingredient

Active Ingredients (in each softgel)

Simethicone 125 mg

Indications and Usage

Use for the relief of

  • pressure, bloating, and 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
Description

Active Ingredients (in each softgel) Simethicone 125 mg

Section 51727-6

Inactive ingredients

D&C yellow#10, FD&C blue#1, gelatin, glycerin, peppermint oil, sorbitol sorbitan, titanium dioxide

Section 53413-1

Questions or comments? 1-888-333-9792

Section 55105-1

Purpose

Antigas

Warning

Carton.jpg

Drug Facts

Keep Out of Reach of Children


Structured Label Content

Active Ingredient (55106-9)

Active Ingredients (in each softgel)

Simethicone 125 mg

Indications and Usage (34067-9)

Use for the relief of

  • pressure, bloating, and 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 (other information)
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
Section 51727-6 (51727-6)

Inactive ingredients

D&C yellow#10, FD&C blue#1, gelatin, glycerin, peppermint oil, sorbitol sorbitan, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 55105-1 (55105-1)

Purpose

Antigas

Warning

Carton.jpg

Drug Facts

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)