Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
A-S Medication Solutions
ORAL
OTC DRUG
relieves bloating, pressure and fullness commonly referred to as gas Antiflatulent
Product: 50090-5431 NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE
OTC monograph final
SIMETHICONE 80 MG- SIMETHICONE TABLET, CHEWABLE A-S MEDICATION SOLUTIONS _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 80 MG _DRUG FACTS_ _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 then 6 tablets per day _OTHER INFORMATION_ store at room temperature 15°-30°C (59°-86°F) _INACTIVE INGREDIENTS_ compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid _QUESTIONS OR COMMENTS?_ call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: RELIABLE 1 LABORATORIES LLC VALLEY STREAM, NY 11580 WWW.RELIABLE1LABS .COM _ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)_ Simethicone 80 mg _PURPOSE_ Antiflatulent HOW SUPPLIED Product: 50090-5431 NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE SIMETHICONE 80 MG simethicone tablet, chewable PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:50 0 9 0 -5431(NDC:6 9 6 18 -0 33) 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 INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) MALTO DEXTRIN (UNII: 7CVR7L4A2D) SO RBITO L (UNII: 50 6 T6 0 A25R) STEARIC ACID (UNII: 4ELV7Z6 5AP) SUCRO SE (UNII: C151H8 M554) DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2) PEPPERMINT (UNII: V9 5R5KMY2B) PRODUCT CHARACTERISTICS COLOR white (Off White) S CORE no sco re S HA Read the complete document