FLUORIDE - fluoride tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Mayne Pharma Inc

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

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._
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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