GAS RELIEF EXTRA STRENGTH- simethicone tablet, chewable
Family Dollar Services 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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Family Wellness 44-608-Delisted

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

cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, FD&C red #40 aluminum lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate

Questions or comments?

1-800-426-9391

Principal display panel

FAMILY
wellness™

COMPARE TO THE ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*

Extra Strength
Gas Relief
Simethicone 125 mg / Anti-Gas

Relieves Gas, Bloating,
Pressure, and Fullness

18 TABLETS

CHEWABLE CHERRY FLAVORED TABLETS

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 ORG031360844

Not 100% satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD.
MATTHEWS, NC 28105 USA

Family Wellness 44-608

GAS RELIEF EXTRA STRENGTH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-608
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
CHERRY (UNII: BUC5I9595W)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTRATES (UNII: G263MI44RU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

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	Marketing End Date
Packaging
1	NDC:55319-608-44	2 in 1 CARTON	07/01/2013	07/21/2017
1		9 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	07/01/2013	07/21/2017

Labeler - Family Dollar Services Inc (024472631)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(55319-608)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(55319-608)

Revised: 5/2017

Document Id: 5c00f812-b2e8-4e15-9a42-9bfaf5be6393

Set id: 8caf6293-a034-4572-932e-ad5cfbbbe8f5

Version: 3

Effective Time: 20170519

Family Dollar Services Inc