Otc - Active Ingredient
Active ingredients
Calcarea sulphurica (Calcium sulfate) 6X
Calcarea Sulfurica 6x Tablet
FDA Label NDC 62106-1052
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 Sulfurica 6x (NDC 62106-1052). 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 - keep out of reach of children, otc - pregnancy or breast feeding, other safety information, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the temporary relief of symptoms associated with
skin irritation
tender gums
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
health professional before use.
Keep out of reach of children. In case of
overdose, get medical help or contact a
Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
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
health professional before use.
Other Safety Information
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
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
skin irritation
tender gums
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.
Package Label.Principal Display Panel
NDC 62106-1052-2
UNDA
tissue salt
CALCAREA SULFURICA 6X
Homeopathic Remedy
Schuessler Salt
For the temporary relief of symptoms associated with skin irritation and tender gum.
100 Tablets
* Please review the disclaimer below.
