Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Proficient Rx LP
DIMETHICONE
DIMETHICONE 80 mg
ORAL
OTC DRUG
Anti-Gas Relieves bloating and pressure commonly referred to as gas.
OTC monograph final
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._ ---------- 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 • • • 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 (800) 795-9775. 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: • • • 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 Прочитајте комплетан документ