GAS RELIEF EXTRA STRENGTH- simethicone tablet, chewable

gas relief by

Drug Labeling and Warnings

gas relief by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Use

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

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults: chew 1 or 2 tablets as needed after meals and at bedtime
• do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

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 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?

1-877-932-7948

Principal display panel

NDC: 41163-635-44             compare to Gas-X® Extra Strength active ingredient*

EQUALINE®

extra strength
gas relief
tablets

simethicone 125mg
(anti-gas)

peppermint
creme flavor

relieves:
bloating
pressure
discomfort

18 chewable tablets                          actual size

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

DOES NOT CONTAIN GLUTEN                                    50844     ORG091363544

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

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
we're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com. Please have package available.

Equaline 44-635

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-635
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)
DEXTRATES (UNII: G263MI44RU)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRIACETIN (UNII: XHX3C3X673)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

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: 41163-635-44	2 in 1 CARTON	10/01/2013
1		9 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	10/01/2013

Labeler - SUPERVALU INC. (006961411)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(41163-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(41163-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(41163-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41163-635)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(41163-635)