Flura-Drops

Name: Flura-Drops

What is Flura-Drops (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

Fluoride may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Flura-Drops (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment.

Talk to your doctor and dentist before taking fluoride if you are breast-feeding.

The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

What should I avoid while taking Flura-Drops (fluoride)?

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

Flura-Drops (fluoride) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have any of the following side effects:

  • discolored teeth;

  • weakened tooth enamel; or

  • any changes in the appearance of your teeth.

Less serious side effects may include:

  • stomach upset;

  • headache; or

  • weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storage

Store at Controlled Room Temperature, 20–25 °C (68–77 °F). See USP Controlled Room Temperature.

NDC: 58223-517-24

Principal display panel

KIRKMAN LABORATORIES, INC.

Flura-Drops
Four Single Drops (0.2cc) contain: NaF 2.21mg representing 1.0 mg of the Fluoride Ion

CAUTION: U.S. Federal law prohibits dispensing without prescription.

Ingredients: Purified Water USP, Sodium Fluoride USP, Methylparaben, Propylparaben.

Manufactured by
KIRKMAN LABORATORIES, INC.
Lake Oswego, OR 97035

24cc 

NDC 58223-517-24

CAUTION: U.S. Federal Law prohibits dispensing without prescription.

The packaging of this product contains dry natural rubber.
 

KIRKMAN®

Kirkman Laboratories Inc.
17387 SW 63rd Ave.
Lake Oswego. OR 97035

Flura-Drops®

SODIUM FLUORIDE

FOUR SINGLE DROPS (0.2cc) CONTAIN: NaF 2.21 mg. representing 1.0 mg. of the Fluoride Ion

NDC 58223-517-24

CAUTION: U.S. Federal Law prohibits dispensing without prescription

24 cc

The packaging of this product contains: Dry natural rubber. 

Mfg By:
Kirkman Laboratories, Inc.,
Lake Oswego, OR 97035

See outer carton for ingredients.

FL046

Flura-Drops  
sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58223-517
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 2.21 mg  in .2 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Methylparaben  
Propylparaben  
Packaging
# Item Code Package Description
1 NDC:58223-517-24 1 BOTTLE, DROPPER in 1 BOX
1 24 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2014
Labeler - KIRKMAN GROUP, INC. (095275447)
Establishment
Name Address ID/FEI Operations
KIRKMAN LABORATORIES INC 180802803 MANUFACTURE(58223-517)
Revised: 05/2014   KIRKMAN GROUP, INC.
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