PLUSPHARMA- simethicone tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 80 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-Gas Relieves bloating and pressure commonly referred to as gas.

Authorization status:

OTC monograph final

Summary of Product characteristics

PLUSPHARMA- SIMETHICONE TABLET, CHEWABLE
PROFICIENT RX LP
_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 TABLET)
Simethicone 80 mg, USP
PURPOS E
Anti-Gas
US ES
Relieves bloating and pressure commonly referred to as gas.
WARNINGS
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DIRECTIONS
•
•
OTHER INFORMATION
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•
•
INACTIVE INGREDIENTS
Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor,
Silicon Dioxide, Sorbitol, Starch and
Stearic Acid.
QUES TIONS ?
If you have any questions or comments, or to report an adverse event,
please contact [phone].
PRINCIPAL DISPLAY PANEL
PlusPHARMA
SIMETHICONE 80 mg
Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
Do not exceed 6 tablets per day except under the advice and
supervision of a physician.
Store at room temperature.
Avoid high humidity.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
ANTI GAS
Acts Fast to Relieve:
•
•
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Compare to the Active Ingredient in Gas-X® Chewables.
This product is not manufactured or distributed by Novartis Consumer
Health, Inc., owner of the
registered trademark Gas-X® Chewables.
100 CHEWABLE TABLETS 80mg Each
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
PLUSPHARMA
simethicone tablet, chewable
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 318 7-516 (NDC:516 45-8 6 0 )
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
8 0 mg
Bloating
Discomfort
Pressure
Proficient Rx LP
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FRUCTO SE (UNII: 6 YSS42VSEV)
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
SO RBITO L