Otc - Active Ingredient
Active Ingredients
Calcarea fluorica (Calcium fluoride) 6X
Calcarea Fluorica 6x Tablet
FDA Label NDC 62106-1050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Calcarea Fluorica 6x (NDC 62106-1050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, otc - ask doctor, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For the temporary relief of symptoms associated
with cracking of joints and minor joint pain.
Warnings
Warnings
Do not use if you ever had an allergic reaction to this product or any of its ingredients.
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a healthcare practitioner before use.
Keep out of reach of children.
In case of overdose, get medical help or contact
a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a healthcare practitioner before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact
a Poison Control Center right away.
Otc - Ask Doctor
Stop use and ask a doctor if symptoms persist or worsen.
Inactive Ingredient
Inactive Ingredients:
Lactose monohydrate (milk),
magnesium stearate,
sodium carboxymethylcellulose,
xylitol
Dosage & Administration
Directions
Tip bottle slightly allowing for tablets to fall into the cap.
Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
Adults and adolescents (12 years and older)
Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
Indications & Usage
Uses
For the temporary relief of symptoms associated
with cracking of joints and minor joint pain.
Directions
Tip bottle slightly allowing for tablets to fall into the cap.
Use cap to drop tablets into mouth and allow them to dissolve under the tongue.
Adults and Adolescents (12 years and older): Take 1 to 4 tablets, one to
four times daily, or as recommended by your healthcare practitioner.
Children (under 12 years): Take under the direction of your healthcare practitioner.
Other Safety Information
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Contents may not fill package in order
to accommodate required labeling.
Please rely on stated quantity.
Package Label.Principal Display Panel
NDC 62016-1050-2
UNDA
tissue salt
CALCAREA FLUORICA 6X
Homeopathic Preparation
Cell Salt
For the temporary relief of symptoms associated
with cracking of joints and minor joint pain.
100 Tablets
* Please review the disclaimer below.
