Indications and uses
relieves bloating, pressure, or fullness commonly referred to as gas
gas relief
- Manufacturer
- Strategic Sourcing Services LLC
- Effective date
- 2022-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:44:21
Label at a glance#
Productgas relief ultra strength
Active ingredientDIMETHICONE
Label structure10 sections
Dosage and administration
swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician
Storage and handling
store between 15-30ºC (59-86ºF) protect from heat and moisture
Contacts and useful links#
Websitewww.sunmarkbrand.com
www.sunmarkbrand.com
www.sunmarkbrand.comLabel contents#
Full prescribing information#
Active ingredient (in each softgel)
Simethicone 180 mg
Purpose
Antiflatulent (Antigas)
Uses
- relieves bloating, pressure, or fullness commonly referred to as gas
Warnings
Stop use and ask a doctor if
condition persists.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Directions
- swallow one or two softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
Other information
- store between 15-30ºC (59-86ºF)
- protect from heat and moisture
Inactive ingredients
FD&C red #40*, FD&C yellow #6, gelatin, glycerin, purified water, white printing ink*
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT**
Gas Relief
Ultra Strength Antigas
Relieves bloating, pressure, fullness & gas
Simethicone 180 mg
RELIEVES GAS SYMPTOMS
SOFTGELS 180 mg EACH
**This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of Phazyme® Ultra Strength
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Please visit us at www.sunmarkbrand.com
Product Label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-0063-1 | EA - Each | 70677-0063 | e0217d36-9a55-4981-be68-98d2420e5278 | 1 | 2020-01-03 |
Products#
Every source-derived product name is available through these pages.
- gas relief ultra strength
- Simethicone
- DIMETHICONE
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- WATER
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70677-0063 | 70677-0063-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| 62b09b47-a236-4734-b5bb-b5f1fc190fbf | 8b898dd5-d062-4b52-8b1f-a3ec0cc9f3ec | 2022-12-15 | Warnings | 62b09b47-a236-4734-b5bb-b5f1fc190fbf 8b898dd5-d062-4b52-8b1f-a3ec0cc9f3ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.