Yyba (as Pld) - Welmate Gas Relief - Simethicone 125 Mg (73581-301)

Yyba (as Pld) - Welmate Gas Relief - Simethicone 125 Mg (73581-301)
SPL v4
SPL
SPL Set ID cc79435e-6d4b-b283-e053-2995a90a8db3
Route
ORAL
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Sorbitol Solution 70% Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin Titanium Dioxide Glycerin Peppermint Oil Povidone Water

Identifiers & Packaging

Pill Appearance
Imprint: YH3 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-20

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

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



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

Questions?

call toll free 1-866-933-6337

Active Ingredient

Simethicone 125 mg

Other Information

■ store at 20° to 25°C (68° to 77°F)



■ protect from light, heat and moisture

Inactive Ingredients

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.


Structured Label Content

Uses

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Antigas

Warnings

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



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

Questions?

call toll free 1-866-933-6337

Active Ingredient (Active ingredient)

Simethicone 125 mg

Other Information (Other information)

■ store at 20° to 25°C (68° to 77°F)



■ protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)