Label: CALCAREA SULFURICA 6X- calcium sulfate tablet
- NDC Code(s): 62106-1052-2
- Packager: Seroyal USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
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
- PREGNANCY OR BREAST FEEDING
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
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 withskin 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
-
INGREDIENTS AND APPEARANCE
CALCAREA SULFURICA 6X
calcium sulfate tabletProduct 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)
