GAS RELIEF SIMETHICONE

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Effective date: 2026-07-31
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: daily-update
Hydrated at: 2026-08-04 03:32:49

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure12 sections

Indications and uses

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

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact804-270-4498

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each chewable tablet)

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC 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:

80mg

NDC 71610-607-02, Bottles of 2 Chewable Tablets
NDC 71610-607-04, Bottles of 4 Chewable Tablets

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:
Aphena
Cookeville, TN 38506
20260731AMH

PRINCIPAL DISPLAY PANEL - 80 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-607 - Simethicone 80 mg Chewable Tablets
Label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	(716)10060702		71610-0607-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-607-04	EA - Each	71610-607	f832fb39-307f-4d6a-a612-8a63bf7ec358	1	2021-12-08
54738-518-01	EA - Each	54738-518	a5c24841-d4d6-4807-bdce-d40c01f1e628	1	2017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Simethicone
DIMETHICONE
DEXTROSE
SUCROSE
MALTODEXTRIN
PEPPERMINT
SORBITOL
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71610-607	71610-607-04, 71610-607-02
54738-518

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
DEXTROSE	IY9XDZ35W2	IACT
SUCROSE	C151H8M554	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
PEPPERMINT	V95R5KMY2B	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2025-01-09	full-release	2026-06-01 00:52:21

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone	SIMETHICONE	Aphena Pharma Solutions - Tennessee, LLC	da0cc98e-1692-405a-ab81-420d6f9df6de	2026-07-31	Warnings	Exact identifier ndc (package): 71610-607-04 ndc (package): 71610-607-02 ndc (product): 71610-607 ndc11 (package): 71610060704 ndc11 (package): 71610060702 spl id: 57e89b75-97c2-f188-e063-6294a90a6cc6 spl set id: da0cc98e-1692-405a-ab81-420d6f9df6de
Simethicone	SIMETHICONE	Richmond Pharmaceuticals, Inc.	f4be1c0d-01fc-4681-9068-905ed3184534	2017-10-30	Warnings	Exact identifier ndc (product): 54738-518

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.