Gas Relief by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) Drug Facts

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

  • for the relief of 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

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours unless directed by a doctor

Other information

  • store at controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*may contain this ingredient

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient in Gas-X®**

Extra Strength

Gas Relief

Antigas

Simethicone 125 mg

Fast relief of:

  • Discomfort
  • Pressure
  • Bloating

Softgels

Small, easy to swallow

**This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®.

Distributed by Dolgencorp, LLC    

100 Mission Ridge, Goodlettsville, TN 37072

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Simethicone 125 mg

Dollar General Extra Strength Gas Relief Softgels

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55910-042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO;S1;SCU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55910-042-724 in 1 CARTON11/20/201301/01/2020
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/20/201301/01/2020
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 12/2018
Document Id: 914e725d-b892-4a76-8bfa-0deb63d6afd5
Set id: 7243670c-8a6f-441c-9cf4-89d0a67f3d8c
Version: 3
Effective Time: 20181203
 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)