GAS RELIEF- simethicone tablet, chewable
L.N.K. International, Inc.

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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LNK 44-608

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

do not take more than directed
chew or crush tablets completely before swallowing; do not swallow tablets whole
adults and children 12 years and over: 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
children under 12 years: ask 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from moisture
see end flap for expiration date and lot number

Inactive ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions or comments?

1-800-426-9391

Principal Display Panel - Rite Aid

Rite Aid 44-608

Principal Display Panel - Exchange Select

Exchange select 44-608

Principal Display Panel - Equaline

Equaline 44-608

GAS RELIEF
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-972
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	44;608
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-972-44	2 in 1 CARTON	01/28/2021
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50844-972-22	4 in 1 CARTON	01/28/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/28/2021

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(50844-972)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(50844-972)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(50844-972)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(50844-972)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(50844-972)

Revised: 3/2021

Document Id: d4aca6fd-2602-44cf-bb46-c2af5d87e01a

Set id: 3b9c8577-86a6-4acd-80c4-476cc49fa030

Version: 5

Effective Time: 20210322

L.N.K. International, Inc.