Label: CALCAREA FLUORICA pellet
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NDC Code(s):
37662-0075-1,
37662-0075-2,
37662-0075-3,
37662-0076-1, view more37662-0076-2, 37662-0076-3, 37662-0077-1, 37662-0077-2, 37662-0077-3, 37662-0077-4, 37662-0078-1, 37662-0078-2, 37662-0078-3, 37662-0078-4, 37662-0079-1, 37662-0079-2, 37662-0079-3, 37662-0079-4, 37662-0080-1, 37662-0080-2, 37662-0080-3, 37662-0080-4, 37662-0081-1, 37662-0081-2, 37662-0081-3, 37662-0081-4, 37662-0082-1, 37662-0082-2, 37662-0082-3, 37662-0082-4, 37662-0083-1
- Packager: Hahnemann Laboratories, INC.
- 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 May 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE FORMS & STRENGTHS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- DOSAGE & ADMINISTRATION
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0081 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 1 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0081-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0081-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0081-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0081-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 10 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0082-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0082-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0082-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0082-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0083 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 1 [hp_Q] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 1mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0083-1 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0075 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0075-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0075-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0075-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0079 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 200 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0079-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0079-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0079-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0079-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0076 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_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0076-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0076-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0076-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0078 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 100 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0078-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0078-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0078-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0078-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0080 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 500 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0080-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0080-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0080-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0080-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 CALCAREA FLUORICA
calcarea fluorica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-0077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37662-0077-1 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 2 NDC:37662-0077-2 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/18/2022 3 NDC:37662-0077-3 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 4 NDC:37662-0077-4 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 05/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2022 Labeler - Hahnemann Laboratories, INC. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, INC. 147098081 manufacture(37662-0075, 37662-0076, 37662-0077, 37662-0078, 37662-0079, 37662-0080, 37662-0081, 37662-0082, 37662-0083)
