OTC Medication Information: Gas Relief Ultra Strength

GAS RELIEF ULTRA STRENGTH- dimethicone capsule, liquid filled
Strategic Sourcing Services LLC

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

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 meals
  • do not exceed two softgels per 24 hours 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

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

†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.

Distributed by McKesson

6555 State Highway 161 Irving, TX 75039

www.sunmarkbrand.com

Product Label

Simethicone 180 mg
(click image for full-size original)

SUNMARK Gas Relief

GAS RELIEF ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0084
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
FD&C RED NO. 40
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 05A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70677-0084-1 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (70677-0084-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M002 05/29/2020 07/28/2025
Labeler — Strategic Sourcing Services LLC (116956644)

Revised: 01/2024 Strategic Sourcing Services LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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