País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Freds Inc
DIMETHICONE
DIMETHICONE 125 mg
ORAL
OTC DRUG
Antiflatulent (Antigas) relieves bloating, pressure, or fullness commonly referred to as gas. condition persists
OTC monograph final
GAS RELIEF- SIMETHICONE CAPSULE, LIQUID FILLED FREDS 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 125mg PURPOS E Antiflatulent (Antigas) US E relieves bloating, pressure, or fullness commonly referred to as gas. WARNINGS STOP USE 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 adults: swallow 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician. OTHER INFORMATION store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture INACTIVE INGREDIENTS D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide QUESTIONS OR COMMENTS? call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Extra Strength Gas-X® * Gas Relief Extra Strength Simethicone, 125mg Relief of: bloating, pressure, fullness, gas EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN. *This product is not manufactured ordistributed by Novartis consumer Health, Inc., owner of the registered trademark Extra Strength Gas- X® Distributed by: Fred's Inc. 4300 New getwell rd, memphis, TN 38118 www.fredsinc.com PRODUCT LABEL GAS RELIEF SIMETHICONE 125 MG GAS RELIEF simethicone capsule, liquid filled PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:55315-550 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICO Leer el documento completo