Label: HYDRASTIS CANADENSIS pellet
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NDC Code(s):
37662-1665-1,
37662-1665-2,
37662-1665-3,
37662-1666-1, view more37662-1666-2, 37662-1666-3, 37662-1667-1, 37662-1667-2, 37662-1667-3, 37662-1667-4, 37662-1668-1, 37662-1668-2, 37662-1668-3, 37662-1668-4, 37662-1669-1, 37662-1669-2, 37662-1669-3, 37662-1669-4, 37662-1670-1, 37662-1670-2, 37662-1670-3, 37662-1670-4, 37662-1671-1, 37662-1671-2, 37662-1671-3, 37662-1671-4, 37662-1672-1
- 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 October 3, 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
HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1668 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1668-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1668-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1668-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 4 NDC:37662-1668-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1667 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1667-1 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1667-2 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1667-3 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 4 NDC:37662-1667-4 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1669 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1669-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1669-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1669-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 4 NDC:37662-1669-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1672 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1672-1 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1665 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1665-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1665-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1665-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1666 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1666-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1666-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1666-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1670 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1670-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1670-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1670-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 4 NDC:37662-1670-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 HYDRASTIS CANADENSIS
hydrastis canadensis pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1671 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:37662-1671-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 2 NDC:37662-1671-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 10/03/2022 3 NDC:37662-1671-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 4 NDC:37662-1671-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/03/2022 Labeler - Hahnemann Laboratories, INC. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, INC. 147098081 manufacture(37662-1665, 37662-1666, 37662-1667, 37662-1668, 37662-1669, 37662-1670, 37662-1671, 37662-1672)
