gas relief simethicone 180mg softgel

gas relief simethicone 180mg softgel
SPL v2
SPL
SPL Set ID 51484644-eb45-4282-91c6-289169bcbaf6
Route
oral
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (180 mg)
Inactive Ingredients
peppermint oil gelatin sorbitol sorbitan glycerin fd&c yellow no. 6 titanium dioxide ferrosoferric oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-18

Purpose

Antiflatulent (Antigas)

Description

Simethicone 180 mg


Medication Information

Warnings

Stop use and ask a doctor if condition persists.

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

Uses

relieves

  • bloating
  • pressure
  • fullness commonly referred to as gas
Purpose

Antiflatulent (Antigas)

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 15° to 30°C (59° to 86°F)
Inactive Ingredients

Peppermint oil, Gelatin, Sorbitol, sorbitan anhydrous, Glycerin, Titanium dioxide, FD &C yellow 6/sunset yellow, Black iron oxide.

Description

Simethicone 180 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Questions Or Comments?

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Softgel)

Simethicone 180 mg


Structured Label Content

Warnings

Stop use and ask a doctor if condition persists.

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

Uses

relieves

  • bloating
  • pressure
  • fullness commonly referred to as gas
Purpose

Antiflatulent (Antigas)

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 15° to 30°C (59° to 86°F)
Inactive Ingredients

Peppermint oil, Gelatin, Sorbitol, sorbitan anhydrous, Glycerin, Titanium dioxide, FD &C yellow 6/sunset yellow, Black iron oxide.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Questions Or Comments? (Questions or Comments?)

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Simethicone 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)