País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
L.N.K. International, Inc.
DIMETHICONE
DIMETHICONE 125 mg
ORAL
OTC DRUG
Antigas relieves bloating, pressure, fullness, or stuffed feeling commonly referred to as gas
OTC monograph final
GAS RELIEF EXTRA STRENGTH- SIMETHICONE CAPSULE, LIQUID FILLED L.N.K. INTERNATIONAL, 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._ ---------- QUALITY PLUS 44-664 _ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)_ Simethicone 125 mg _PURPOSE_ Antigas _USE_ relieves bloating, pressure, fullness, or stuffed feeling commonly referred to as gas _WARNINGS_ KEEP OUT OF REACH OF CHILDREN. _DIRECTIONS_ adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime do not exceed 4 capsules in 24 hours unless directed by a doctor _OTHER INFORMATION_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from light, heat and moisture see end flap for expiration date and lot number _INACTIVE INGREDIENTS_ D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, peppermint oil, purified water, titanium dioxide _QUESTIONS OR COMMENTS?_ 1-800-426-9391 PRINCIPAL DISPLAY PANEL QUALITY + PLUS _NDC 50844-964-01_ *Compare to active ingredient in Gas-X Extra Strength GAS RELIEF_ _ SIMETHICONE 125 MG ANTIGAS Relieves: *Pressure *Bloating *Discomfort Easy to Swallow 30 Liquid-filled Capsules ACTUAL SIZE *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X Extra Strength. 50844 ORG121566401 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA Product of China Packaged and Quality Assured in the USA TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING ® EXTRA STRENGTH ® QUALITY PLUS 4 4 -664 GAS RELIEF EXTRA STRENGTH simethicone capsule, liquid filled PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:50 8 44-9 6 4 ROUTE O Leer el documento completo