Simethicone Capsules 250 Mg

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (250 mg)

Inactive Ingredients

D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC31 Shape: capsule Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-06-30

Medication Information

Purpose

Anti-gas

Description

Drug Facts

Use

relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Stop Use and Ask A Doctor If

condition persists

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Principal Display Panel Shipping Label

Simethicone Capsules 250 mg

NDC 53345-032-02

Quantity: 12 Capsules per blister

124 Blisters per box

IMPORTANT:

Inspect immediately 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

Use

relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients (Inactive ingredients)

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists

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

Simethicone 250 mg

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

Simethicone Capsules 250 mg

NDC 53345-032-02

Quantity: 12 Capsules per blister

124 Blisters per box

IMPORTANT:

Inspect immediately 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

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves bloating, pressure or fullness commonly referred to as gas", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "Purpose": "Anti-gas", "Directions": "swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Other information": "store at room temperature 59°-86°F (15°-30°C)", "Inactive ingredients": "D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink", "Stop use and ask a doctor if": "condition persists", "Active ingredient (in each softgel)": "Simethicone 250 mg", "PRINCIPAL DISPLAY PANEL - Shipping Label": "Simethicone Capsules 250 mg NDC 53345-032-02 Quantity: 12 Capsules per blister 124 Blisters per box IMPORTANT: Inspect immediately 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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information