simethicone capsules 125 mg, liquid filled

simethicone capsules 125 mg, liquid filled
SPL v3
SPL
SPL Set ID f7c40b12-11e4-4b85-afb2-0ea33e4f218c
Route
oral
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c red no. 40 d&c yellow no. 10 gelatin glycerin peppermint oil water

Identifiers & Packaging

Pill Appearance
Imprint: 664 Shape: capsule Color: green Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2015-01-28

Purpose

Antigas

Description

Simethicone 125 mg


Medication Information

Warnings

Purpose

Antigas

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 room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
Inactive Ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Description

Simethicone 125 mg

Uses 

for relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 50565-1

Keep out of reach of children.

Active Ingredient (in Each Capsule)

Simethicone 125 mg

Principal Display Panel Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules

NDC. No : 53345-033-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


Structured Label Content

Warnings

Purpose

Antigas

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 room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Uses 

for relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children.

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

Simethicone 125 mg

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

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules

NDC. No : 53345-033-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)