Gas Relief Simethicone

Gas Relief Simethicone
SPL v3
SPL
SPL Set ID da0cc98e-1692-405a-ab81-420d6f9df6de
Route
ORAL
Published
Effective Date 2021-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (80 mg)
Inactive Ingredients
Dextrose Sucrose Maltodextrin Peppermint Sorbitol Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;019 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-03-01

Description

.

Purpose

Antiflatulent


Medication Information

Purpose

Antiflatulent

Description

.

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing
Section 50565-1

Keep out of reach of children

Warnings

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

Directions
  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor
Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pmEST Monday - Friday

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 80 mg
4 71610-607-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20211105JH

Principal Display Panel 80 Mg

NDC 71610-607 - Simethicone 80 mg Chewable Tablets


Structured Label Content

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing
Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antiflatulent

Warnings

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

Directions
  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor
Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pmEST Monday - Friday

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 80 mg
4 71610-607-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20211105JH

Principal Display Panel 80 Mg (PRINCIPAL DISPLAY PANEL - 80 mg)

NDC 71610-607 - Simethicone 80 mg Chewable Tablets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)