GAS RELIEF- simethicone capsule, gelatin coated

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

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-gas relieves bloating, pressure or fullness commonly referred to as gas
Authorization status:
OTC monograph final
Authorization number:
70000-0514-1

GAS RELIEF- simethicone capsule, gelatin coated

Cardinal Health

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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Drug Facts

Active Ingredient

(in each softgel)

Simethicone 250mg

Purpose

Anti-gas

Use

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if condition persists

Keep out of reach of children.

Directions

swallow one or two softgels as symptoms occur

do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

store at room temperature 15ºC to 30ºC (59ºF to 86ºF)

Inactive Ingredients

DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

Questions?

Call toll-free 1-800-706-5575

Principal Display Panel

Cardinal Health - Leader

Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

60 Liquid Filled Softgels

Bottle label

NDC# 70000-0514-1

Principal Display Panel

Cardinal Health - Leader

Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

60 Liquid Filled Softgels

Carton

NDC# 70000-0514-1

GAS RELIEF

simethicone capsule, gelatin coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 514

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

250 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

WATER (UNII: 0 59 QF0 KO0 R)

Cardinal Health

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

purple

S core

no sco re

S hap e

CAPSULE

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 514-1

1 in 1 CARTON

0 7/24/20 19

1

6 0 in 1 BOTTLE; 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 mo no graph final

pa rt332

0 7/24/20 19

Labeler -

Cardinal Health (097537435)

Registrant -

Apotex Inc. (209429182)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Catalent Ontario Limited

248 441727

analysis(70 0 0 0 -0 514) , manufacture(70 0 0 0 -0 514)

Revised: 8/2019

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