País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
EQUATE (Wal-Mart Stores, Inc.)
DIMETHICONE
DIMETHICONE 180 mg
ORAL
OTC DRUG
Antiflatulent (Antigas) - relieves bloating, pressure, or fullness commonly referred to as gas
OTC monograph final
GAS RELIEF ULTRA STRENGTH- SIMETHICONE CAPSULE, LIQUID FILLED EQUATE (WAL-MART STORES, INC.) _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 SOFTGEL) Simethicone 180 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 swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician OTHER INFORMATION store at controlled room temperature 15º-30ºC (59º-86ºF) INACTIVE INGREDIENTS edibile ink, FD&C yellow # 6, gelatin, glycerin and purified water QUESTIONS OR COMMENTS? 1-888-287-1915 PRINCIPAL DISPLAY PANEL Compare to Ultra Strength Phazyme® Active Ingredient* Ultra Strength Gas Relief Anti-Gas/Simethicone Relief of: Gas discomfort Pressure Bloating 180 mg LIQUID-FILLED SOFTGELS Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 ©Wal-Mart Stores, Inc. Product of USA *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN. PACKAGE LABEL EQUATE SIMETHICONE 180 MG ULTRA STRENG TH GAS RELIEF SOFTG ELS GAS RELIEF ULTRA STRENGTH simethicone capsule, liquid filled PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:49 0 35-530 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIMETHICO NE (UNII: 9 Leer el documento completo