Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Western Family Foods, Inc.
DIMETHICONE
DIMETHICONE 125 mg
OTC DRUG
OTC monograph final
ANTIGAS EXTRA STRENGTH- SIMETHICONE CAPSULE, LIQUID FILLED WESTERN FAMILY FOODS, 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 125 mg PURPOS E Antiflatulent US ES for relief of: bloating pressure fullness stuffed feeling 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 ADULTS: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor. OTHER INFORMATION store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas- X® INACTIVE INGREDIENTS D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special. QUESTIONS OR COMMENTS? call toll free 1-877-753-3935 PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Extra Strength Gas-X®* AntiGas Extra Strength Simethicone, 125mg Fast relief of: bloating, pressure, fullness and gas EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION PROUDLY DISTRIBUTED BY: WESTERN FAMILY FOODS, INC. PO BOX 4057, PORTLAND, OR 97208 USA WWW.WES TERNFAMILY.COM PRODUCT LABEL SIMETHICONE 125 MG ANTIGAS EXTRA STRENGTH simethicone capsule, liquid filled PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:55312-550 ROUTE OF ADMINISTRATION ORAL ACTIVE ING Les hele dokumentet