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Gas Relief Extra Strength by Harmon Store Inc.

Medically reviewed on Jul 21, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Harmon Store Inc.
NDC Code: 63940-669

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.

Core Values 44-664

Active ingredient (in each liquid-filled capsule)

Simethicone 125 mg

Purpose

Antigas

Use

relieves bloating, pressure, fullness, or stuffed feeling commonly referred to as gas

Warnings

Keep out of reach of children.

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

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from light, heat and moisture
  • see end flap for expiration date and lot number

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, peppermint oil, purified water, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

COREVALUES™

Compare to active
ingredient in
Gas-X® Extra Strength

NDC 63940-669-62

Extra Strength
Gas Relief
Simethicone 125 mg
ANTI-GAS

Relieves:
• Bloating
• Pressure
• Discomfort

Actual Size

15 Liquid-filled Capsules

Easy to Swallow

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

This product is not manufactured or distributed by Novartis
Consumer Health, Inc., owner of the registered trademark
Gas-X® Extra Strength.           50844              ORG121566462

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Product of China
Packaged and Quality
Assured in the USA

Core Values 44-664

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-669
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN, UNSPECIFIED 
GLYCERIN 
MINERAL OIL 
PEPPERMINT OIL 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code664
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-669-621 BLISTER PACK in 1 CARTON
115 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/01/2015
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287API MANUFACTURE(63940-669)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-669)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-669)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63940-669)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-669)

 
Harmon Store Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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