Sodium Fluoride Chewable Tablets

Name: Sodium Fluoride Chewable Tablets

Uses of Sodium Fluoride Chewable Tablets

  • This supplement is used to prevent cavities.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.

What are some other side effects of Sodium Fluoride Chewable Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.

FLUORIDE 
fluoride tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-172
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg
Inactive Ingredients
Ingredient Name Strength
CHERRY  
LACTOSE, UNSPECIFIED FORM  
SACCHARIN  
D&C RED NO. 7  
MAGNESIUM STEARATE  
Product Characteristics
Color RED Score no score
Shape ROUND Size 6mm
Flavor CHERRY Imprint Code 172
Contains     
Packaging
# Item Code Package Description
1 NDC:51862-172-12 120 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/21/2011 03/31/2020
Labeler - Mayne Pharma Inc (867220261)
Revised: 07/2017   Mayne Pharma Inc
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