GAS RELIEF- simethicone tablet, chewable

Gas Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

Uses

• relieves these symptoms associated with gas:
  • bloating
  • pressure
  • fullness
  • stuffed feeling 

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

• chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
• do not exceed 6 tablets per day unless directed by a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid high humidity and excessive heat above 40ºC (104ºF) 
• use by expiration date on package

Inactive ingredients

dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal Display Panel

NDC: 37205-112-78

LEADER®

Gas Relief
Simethicone 80 mg

Anti Gas
Pressure   Bloating   Discomfort

Fast Acting

SATISFACTION GUARANTEED

Mint Flavored

100 CHEWABLE TABLETS

50844  REV0712G13712

Questions or comments? 1-800-426-9391

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com    1-800-200-6313

CIN 2804144

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader 44-137

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
PEPPERMINT (UNII: V95R5KMY2B)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE (UNII: IY9XDZ35W2)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	44;137
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-112-78	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/28/1994	02/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	07/28/1994	02/04/2023

Labeler - CARDINAL HEALTH (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(37205-112)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(37205-112)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(37205-112)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(37205-112)