CALCAREA FLUORICA tablet, chewable

CALCAREA FLUORICA by

Drug Labeling and Warnings

CALCAREA FLUORICA by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients HPUS*

Calcarea fluorica (Calcium fluoride) 12X

Purpose

...........................................Tissue elasticity, painful joints, dry chapped, cracked skin

REFERENCES

The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Uses

This tissue salt helps improve tissue elasticity, painful joints and dry chapped or cracked skin.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Warnings

Do not use if seal on snap-on lid is broken or missing.

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

As with any drug, ask a doctor before use if pregnant or nursing.

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, contact a medical professional or a Poison Control Center immediately.

Directions

Children from 2 to 5 years: Crush 2 tablets and dissolve in water 3 times daily, or as directed by a healthcare professional.

Adults and children over 5 years: Chew 2 tablets 3 times daily, or as directed by a healthcare professional.

Do not use more than directed.

Do not take with food.

Other information

Store at room temperature.

Inactive ingredients

Lactose, magnesium stearate.

LABEL

INGREDIENTS AND APPEARANCE

CALCAREA FLUORICA 
calcarea fluorica tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-8011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-8011-5	125 in 1 JAR
2	NDC: 60512-8011-6	500 in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/28/2014

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-8011)