SIMETHICONE 125 MG- simethicone tablet, chewable

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
29-09-2022

Aktiv ingrediens:

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

Tilgjengelig fra:

ATLANTIC BIOLOGICALS CORP.

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Antiflatulent relieves bloating, pressure and fullness commonly referred to as gas

Autorisasjon status:

OTC monograph final

Preparatomtale

                                SIMETHICONE 125 MG- SIMETHICONE TABLET, CHEWABLE
ATLANTIC BIOLOGICALS CORP.
_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._
----------
SIMETHICONE 125 MG
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)_
Simethicone 125 mg
Antiflatulent
_USE_
relieves bloating, pressure and fullness commonly referred to as gas
_WARNINGS_
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
_DIRECTIONS_
thoroughly chew 1-2 tablets as needed after meals and at bedtime
do not take more than 4 tablets per day
_OTHER INFORMATION_
store at room temperature 15°-30°C (59°-86°F)
_INACTIVE INGREDIENTS_
compressible sugar, dextrose, maltodextrin, microcrystaline cellulose,
peppermint
flavor, silicon dioxide, sorbitol, stearic acid
_QUESTIONS OR COMMENTS?_
call 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the
trademark Mylanta®
Distributed by:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
NDC 17856-0137-01
SIMETHICONE 125 MG
ANTIFLATULENT
100CT CHEWABLE TABLETS
SIMETHICONE 125 MG
simethicone tablet, chewable
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:17856-0137(NDC:69618-032)
ROUTE OF ADMINISTRATION
ORAL
ATLANTIC BIOLOGICALS CORP.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
125 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE (UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PRODUCT CHARACTERISTICS
COLOR
white (Off white)
SCORE
2 pieces
SHAPE
ROUND
SIZE
16mm
FLAVOR
IMPRINT CODE
                                
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