GAS RELIEF- simethicone tablet, chewable

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

• chew or crush tablets completely before swallowing: do not swallow tablets whole
• adults: take 1 or 2 chewable tablets as needed after meals and at bedtime
  
• do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
  

Other information

• each tablet contains: calcium 85 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
•  store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• protect from moisture
  
• see end flap for expiration date and lot number
  

Inactive ingredients

D&C yellow #10 aluminum lake, dextrates, flavors, maltodextrin, silicon dioxide, sorbitol, starch, stearic acid, talc, triacetin, tri-calcium phosphate

Questions or comments?

1-800-426-9391

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CORE VALUES™

Compare to active ingredient in Gas-X® Extra Strength†

Extra Strength

Gas Relief

Simethicone 125 mg
Chewable Tablets
Anti-Gas

Relieves:
Bloating
Pressure
Discomfort

Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.

48 chewable tablets

Actual Size

peppermint crème flavor

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

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR 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 REV0119A63522

Core Values 44-635

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-635
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	PEPPERMINT (PEPPERMINT CREME)	Imprint Code	44;635
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-635-22	4 in 1 CARTON	11/09/2018
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	11/09/2018

Labeler - Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(63940-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63940-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63940-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63940-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63940-635)