CALCAREA SULFURICA 6X- calcium sulfate tablet

CALCAREA SULFURICA 6X by

Drug Labeling and Warnings

CALCAREA SULFURICA 6X by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Calcarea sulphurica (Calcium sulfate) 6X

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.

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

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.

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

INGREDIENTS AND APPEARANCE

CALCAREA SULFURICA 6X 
calcium sulfate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-1052
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-1052-2	1 in 1 CARTON	09/01/2017
1		100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2017

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-1052)