GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
MEIJER, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antigas For the relief of pressure and bloating commonly referred to as gas.
Authorization status:
OTC monograph final
Authorization number:
41250-343-50

GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled

MEIJER, 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.

----------

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpos e

Antigas

Us es

For the relief of pressure and bloating commonly referred to as gas.

Warnings

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

adult: swallow with water 1 or 2 softgels as needed after meal and at bedtime

do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other information

store between 15-30ºC (59º-86ºF)

protect from heat and moisture

Inactive ingredients

FD&C red #40*, FD&C yellow # 6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Gas-X Ultra Strength active ingredient†

ULTRA STRENGTH

gas relief

Simethicone | 180 mg

FAST RELIEF OF:

Gas, Pressure, Bloating, Discomfort

Softgels

SMALL, EASY TO SWALLOW

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X®

Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN, OR SHOW ANY

SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPID, MI 49544

www.meijer.com

Package Label

MEIJER Ultra Streng th Gas Relief

GAS RELIEF ULTRA STRENGTH

simethicone capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -343

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

18 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MEIJER, INC.

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

S18 0 ;0 5A

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -343-50

50 in 1 CARTON

0 2/28 /20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt332

0 2/28 /20 19

Labeler -

MEIJER, INC. (006959555)

Revised: 7/2020

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