Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Mayne Pharma Inc
SODIUM FLUORIDE
FLUORIDE ION 0.5 mg
ORAL
PRESCRIPTION DRUG
Active Ingredient: 0.5 mg of fluoride ion from 1.1 mg of sodium fluoride (NaF). Inactive Ingredients: Lactose, Saccharine, Grape Flavor and Magnesium Stearate.
unapproved drug other
FLUORIDE - FLUORIDE TABLET, CHEWABLE MAYNE PHARMA INC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- FLUORIDE CHEWABLE TABLETS 0.5 MG ACTIVE INGREDIENT: 0.5 mg of fluoride ion from 1.1 mg of sodium fluoride (NaF). INACTIVE INGREDIENTS: Lactose, Saccharine, Grape Flavor and Magnesium Stearate. DOSAGE AND ADMINISTRATION: Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. STORAGE: Store at a Controlled Room Temperature 20º-25ºC (68º-77ºF) 743633 Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 171-10 CONTAINER LABEL NDC 51862-171-10 FLUORIDE CHEWABLE TABLETS 0.5 MG (FROM 1.1 MG OF SODIUM FLUORIDE) GRAPE FLAVOR 1000 TABLETS RX ONLY Libertas Pharma Inc. Mayne Pharma Inc FLUORIDE fluoride tablet, chewable PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:518 6 2-171 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 0 .5 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GRAPE (UNII: 6 X543N6 8 4K) LACTO SE, UNSPECIFIED FO RM (UNII: J2B2A4N9 8 G) SACCHARIN (UNII: FST46 7XS7D) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) PRODUCT CHARACTERISTICS COLOR PURPLE S CORE no sco re S HAP E ROUND S IZ E 6 mm FLAVOR GRAPE IMPRINT CODE 171 CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:518 6 2-171-10 10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/21/20 11 11/30 /20 18 2 NDC:518 6 2-171-12 120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/21/20 11 0 3/31/20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE Unappro ved drug o ther 0 5/21/20 11 0 3/31/20 20 LABELER - Mayne Pharma Inc (867220 Lesen Sie das vollständige Dokument