simethicone capsules 180 mg

simethicone capsules 180 mg
SPL v2
SPL
SPL Set ID 346df37d-b0fc-4fa5-8c19-492fed58c239
Route
oral
Published
Effective Date 2016-07-25
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 water

Identifiers & Packaging

Pill Appearance
Imprint: 667 Shape: capsule Color: orange Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2016-07-25
Purpose

Anti-gas

Description

Simethicone 180 mg

Medication Information

Warnings and Precautions

Warnings

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Purpose

Anti-gas

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

Description

Simethicone 180 mg

Section 50565-1

Keep out of reach of children. 

Section 50566-9

Stop use and ask a doctor ifcondition persists

Active Ingredient (in Each Capsule)

Simethicone 180 mg

Principal Display Panel Shipping Label

SIMETHICONE CAPSULES, 180 mg

Quantity : 25000 Capsules

NDC. No : 53345-036-01

IMPORTANT:

  • Inspect immediate upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Purpose

Anti-gas

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

Section 50565-1 (50565-1)

Keep out of reach of children. 

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition persists

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

Simethicone 180 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

SIMETHICONE CAPSULES, 180 mg

Quantity : 25000 Capsules

NDC. No : 53345-036-01

IMPORTANT:

  • Inspect immediate upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:32.340338 · Updated: 2026-03-14T23:05:21.514130