Indications and uses
relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing
Simethicone
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Effective date
- 2013-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:06:00
Label at a glance#
ProductSimethicone
Active ingredientDIMETHICONE
Label structure12 sections
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 physician
Label contents#
Full prescribing information#
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 physician
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 OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.
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 | 67544-767-04 |
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
20171222DKJ
PRINCIPAL DISPLAY PANEL - 80mg
NDC 67544-767 Simethicone (MTAB) 80mg - Rx Only
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67544-767-04 | EA - Each | 67544-767 | a4edb1d3-fdb8-4c42-9f4f-3506036012c5 | 1 | 2018-01-12 |
| 0603-0210-21 | EA - Each | 0603-0210 | f9910cc9-0511-416b-b5ca-dd70d94092bb | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Simethicone
- DIMETHICONE
- DEXTROSE
- SUCROSE
- MALTODEXTRIN
- PEPPERMINT
- SORBITOL
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67544-767 | 67544-767-04 |
| 0603-0210 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3635409d-509b-df95-e063-6294a90a9561 | 9e9f4c61-df0b-43c2-8887-2371cdd12ebc | 2025-05-28 | Warnings | 9e9f4c61-df0b-43c2-8887-2371cdd12ebc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.