Label: ARNICA MONTANA pellet
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NDC Code(s):
63545-159-01,
63545-159-02,
63545-159-03,
63545-160-01, view more63545-160-02, 63545-160-03, 63545-161-01, 63545-161-02, 63545-161-03, 63545-161-04, 63545-162-01, 63545-162-02, 63545-162-03, 63545-162-04, 63545-163-01, 63545-163-02, 63545-163-03, 63545-163-04, 63545-164-01, 63545-164-02, 63545-164-03, 63545-164-04, 63545-165-01, 63545-165-02, 63545-165-03, 63545-165-04, 63545-166-01, 63545-166-02, 63545-166-03, 63545-166-04, 63545-167-01
- 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 March 12, 2021
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
ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-166 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-166-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-166-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-166-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-166-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-165 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-165-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-165-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-165-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-165-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-162-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-162-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-162-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-162-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-167 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-167-01 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-159 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-159-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-159-02 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-159-03 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-164 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-164-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-164-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-164-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-164-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-160-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-160-02 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-160-03 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-161-01 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-161-02 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-161-03 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-161-04 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 ARNICA MONTANA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 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:63545-163-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 2 NDC:63545-163-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 03/12/2021 3 NDC:63545-163-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 4 NDC:63545-163-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/2021 Labeler - Hahnemann Laboratories, Inc. (147098081) Registrant - Hahnemann Laboratories, Inc. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, Inc. 147098081 manufacture(63545-159, 63545-160, 63545-161, 63545-162, 63545-163, 63545-164, 63545-165, 63545-166, 63545-167)
