SIMETHICONE tablet, chewable

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

Uses

relieves

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

Warnings

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

Keep out of reach of children

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

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 pm EST 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

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-607(NDC:54738-518)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	AP;019
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-607-04	4 in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	03/01/2011

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-607)