Label: HELONIAS DIOICA pellet
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NDC Code(s):
37662-1497-1,
37662-1497-2,
37662-1497-3,
37662-1498-1, view more37662-1498-2, 37662-1498-3, 37662-1499-1, 37662-1499-2, 37662-1499-3, 37662-1499-4, 37662-1500-1, 37662-1500-2, 37662-1500-3, 37662-1500-4, 37662-1501-1, 37662-1501-2, 37662-1501-3, 37662-1501-4, 37662-1502-1, 37662-1502-2, 37662-1502-3, 37662-1502-4, 37662-1503-1, 37662-1503-2, 37662-1503-3, 37662-1503-4, 37662-1504-1, 37662-1504-2, 37662-1504-3, 37662-1504-4
- 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 September 12, 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
HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1500 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1500-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1500-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1500-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1500-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1504-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1504-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1504-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1504-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1502 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1502-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1502-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1502-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1502-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1501 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1501-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1501-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1501-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1501-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1503 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1503-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1503-2 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1503-3 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1503-4 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1497 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1497-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1497-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1497-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1498 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1498-1 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1498-2 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1498-3 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 HELONIAS DIOICA
helonias dioica pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37662-1499 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 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:37662-1499-1 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 2 NDC:37662-1499-2 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 09/13/2022 3 NDC:37662-1499-3 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 4 NDC:37662-1499-4 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/13/2022 Labeler - Hahnemann Laboratories, INC. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, INC. 147098081 manufacture(37662-1497, 37662-1498, 37662-1499, 37662-1500, 37662-1501, 37662-1502, 37662-1503, 37662-1504)
