GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
Family Dollar (FAMILY WELLNESS)

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

Warnings

If pregnant of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*

Gas Relief

SIMETHICONE 125 mg ANTIGAS

FAST RELIEF OF

PRESSURE - BLOATING - DISCOMFORT

EXTRA STRENGTH

SOFTGELS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC 

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Product Label

Simethicone 125 mg

FAMILY WELLNESS Extra Strength Gas Relief


GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-487
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)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO;SCU;L125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-487-5050 in 1 CARTON02/29/201610/30/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:55319-487-3030 in 1 CARTON02/29/201610/30/2025
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/29/201610/30/2025
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 1/2023
Document Id: 6cade8c6-ba85-4b09-ba05-d8a1bfa2d432
Set id: 45e5a1bb-bd75-4c0f-8c7b-ef13fc49acfa
Version: 6
Effective Time: 20230125
 
Family Dollar (FAMILY WELLNESS)