FLOURIDE A DAY- sodium fluoride tablet, chewable 
Bryant Ranch Prepack

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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Flouride A Day

Each 1.0 mg Fluoride Tablet Contains:

*
Each 1.0 mg Fluoride Tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride (NaF).
Fluoride (as Sodium Fluoride)*1.0 mg

WARNING

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS PRODUCT, AS WITH ALL CHEWABLE TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE 4 DUE TO RISK OF CHOKING.

DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Description

White to off-white, orange flavor, round-shaped chewable tablet debossed "SCI" on one side and "4" on the other.

See inside panel for additional information

Caution

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Other Ingredients

Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, natural orange flavor, sucralose.

Storage

Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.

This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA

rev. 12/02/11

HOW SUPPLIED

Product: 63629-4730

NDC: 63629-4730-1 120 TABLET, CHEWABLE in a BOTTLE

Flouride A Day Chew Tablet

Label Image
FLOURIDE A DAY 
sodium fluoride tablet, chewable
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-4730(NDC:44946-1010)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg
Inactive Ingredients
Ingredient NameStrength
Xylitol (UNII: VCQ006KQ1E)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Malic Acid (UNII: 817L1N4CKP)  
Magnesium Stearate (UNII: 70097M6I30)  
Talc (UNII: 7SEV7J4R1U)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITE (White to off white) Scorescore with uneven pieces
ShapeROUNDSize13mm
FlavorORANGEImprint Code SCI;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4730-1 120 in 1 BOTTLE; Type 0: Not a Combination Product06/04/201208/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other12/20/201108/30/2016
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4730) , RELABEL(63629-4730)

Revised: 6/2017
 
Bryant Ranch Prepack