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NDC 71610-0649-04 SIMETHICONE 80 mg/1 Details

SIMETHICONE 80 mg/1

SIMETHICONE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 71610-0649-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	71610-0649
Product ID	71610-649_b90721af-b67e-4a2e-b05c-a679f5842c0e
Associated GPIs	52200020000510
GCN Sequence Number	002821
GCN Sequence Number Description	simethicone TAB CHEW 80 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	08281
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
Proprietary Name	SIMETHICONE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	80
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0649-04 (71610064904)

Pricing Information	N/A
NDC Package Code	71610-649-04
Billing NDC	71610064904
Package	4 TABLET, CHEWABLE in 1 BOTTLE (71610-649-04)
Marketing Start Date	2022-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5df94be7-0bc9-4be1-9982-8193e3a3c8ef Details

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

relieves pressure, bloating, and fullness

commonly referred to as gas

Warnings

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

Keep out of reach of children.

Directions

chew or crush tablet completely before swallowing
adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

children under 12 years: ask a doctor

Other information

each tablet contains: calcium 65 mg
Tamper Evident: Do not use if imprinted seal under cap is missing or broken
store at room temperature, 15°C - 30°C (59˚F - 86˚F)
protect from moisture

HOW SUPPLIED

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as:

NDC 57896-791-01 in bottle of 100 chewable tablets

NDC 57896-791-08 in bottle of 80 chewable tablets

Distributed by:

GERI-CARE Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,

magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

1-800-540-3765

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	71610-649-04

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

20220519JK

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only

INGREDIENTS AND APPEARANCE

SIMETHICONE

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-649(NDC:57896-791)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DEXTRATES (UNII: G263MI44RU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	44;137
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71610-649-04	4 in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/01/2004

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

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-649)

Revised: 6/2022

Document Id: b90721af-b67e-4a2e-b05c-a679f5842c0e

Set id: 5df94be7-0bc9-4be1-9982-8193e3a3c8ef

Version: 2

Effective Time: 20220617