FLORIVA- cholecalciferol and sodium fluoride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

BonGeo Pharmaceuticals, Inc.

INN (International Name):

CHOLECALCIFEROL

Composition:

CHOLECALCIFEROL 400 [iU] in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper. Do not accept if tamper evident box seal is broken or missing. The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

Authorization status:

unapproved drug other

Summary of Product characteristics

FLORIVA- CHOLECALCIFEROL AND SODIUM FLUORIDE LIQUID
BONGEO PHARMACEUTICALS, 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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FLORIVA
0.25 MG DROPS
SUPPLEMENT FACTS
SERVING SIZE: 1 ML
SERVINGS PER CONTAINER: 50
AMOUNT
PER
SERVING
% DAILY
VALUE
*
†
Vitamin D
400 IU
100%
Fluoride (sodium fluoride)
0.25 mg
OTHER INGREDIENTS: Glycerin, water, polysorbate 80, sodium hydroxide,
propylene
glycol, sucralose, fruit flavor, methyl paraben, caramel color and
propyl paraben.
WARNING
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS
SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON
CONTROL CENTER IMMEDIATELY 1-800-222-1222.
SHAKE WELL BEFORE USE
DIRECTIONS
Use as directed by a physician
HOW TO USE
Fill dropper to appropriate line and dispense with a single squeeze of
the dropper bulb.
The full dose will be given. It is normal for a small amount to remain
in the tip of the
dropper.
Do not accept if tamper evident box seal is broken or missing.
THE MANUFACTURER OF THIS PRODUCT REQUIRES THAT IT BE DISPENSED ONLY
UNDER
THE ORDER OF A PHYSICIAN OR LICENSED MEDICAL PRACTITIONER.
™
*
Percent Daily Value (%DV) based on a 2000 calorie diet.
Daily Value not established.
†
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) since these may decrease effectiveness. Prolonged
daily ingestion of
excessive fluoride may result in varying degrees of dental fluorosis.
OTHER INFORMATION
You may report serious side effects to 1-844-640-7607.
The numeric identifer 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 registr