Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Remedy Makers
SUBLINGUAL
PRESCRIPTION DRUG
unapproved homeopathic
CODEINUM- CODEINE PELLET REMEDY MAKERS _Disclaimer: This homeopathic product has not been evaluated by the Food and Drug_ _Administration for safety or efficacy. FDA is not aware of scientific evidence to support_ _homeopathy as effective._ ---------- CII WARNING "The FDA has not determined that the product is safe, effective and not misbranded for its intended use" INDICATION: VERTIGO, DIARRHEA, PAIN OR OTHER INDICATIONS WARNING: Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast- feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area. DIRECTIONS (ADULT/CHILDREN) Dissolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose. INACTIVE INGREDIENTS Lactose and Sucrose. Free from yeast, wheat, corn and soy. OTHER INFORMATION Contains approx. 170 - 172 pellets. QUESTIONS OR COMMENTS: (877) REM4YOU Fax (909) 594-4205 Pomona, Ca. 91768 USA www.remedymakers.com CAUTION: Federal law prohibits dispensing withhout prescription. CODEINUM Remedy Makers codeine pellet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:10191-1035 ROUTE OF ADMINISTRATION SUBLINGUAL DEA SCHEDULE CII ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE ANHYDROUS 9 [hp_X] INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SUCROSE (UNII: C151H8M554) LACTOSE (UNII: J2B2A4N98G) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:10191- 1035-2 170 in 1 VIAL, GLASS; Type 0: Not a Combination Product 07/14/2015 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE unapproved homeopat Aqra d-dokument sħiħ