GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

Valu Merchandisers Company (Best Choice)

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 125 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiflatulent (Antigas) - relieves bloating, pressure, or fullness commonly referred to as gas.

Authorization status:

OTC monograph final

Summary of Product characteristics

GAS RELIEF EXTRA STRENGTH- SIMETHICONE CAPSULE, LIQUID FILLED
VALU MERCHANDISERS COMPANY (BEST CHOICE)
_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 125 mg
PURPOS E
Antiflatulent (Antigas)
US E
relieves bloating, pressure, or fullness commonly referred to as gas.
WARNINGS
STOP USING THIS PRODUCT AND ASK A DOCTOR IF
condition persists
IF PREGNANT OR BREAST-FEEDING,
ask a health care professional before use
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
ADULTS: swallow with water 1 or 2 softgels as needed after meals and
at bedtime.
do not exceed 4 softgels in 24 hours except under the advice and
supervision of a physician.
OTHER INFORMATION
store at controlled room temperature 15°-30°C (59°-86°F)
protect from heat and moisture
*This product is not manufactured or distributed by Novartis Consumer
Health Inc., owner of the
registered trademark Extra Strength Gas- X®
INACTIVE INGREDIENTS
D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin,
glycerin, peppermint oil,
purified water, sorbitol special and titanium dioxide.
QUESTIONS OR COMMENTS?
call toll free: 1-877-753-3935 MONDAY-FRIDAY 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient in Extra Strength Gas-X®
Extra Strength
Gas Relief
Simethicone, 125mg
Relieves symptoms of
bloating
pressure
fullness
gas
EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.
DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
PRODUCT LABEL
SIMETHICONE 125 MG
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 39 41-550
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF