Label: CATEGORY I- immune system booster liquid
- NDC Code(s): 64616-082-02
- Packager: Vitality Works, 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 December 28, 2023
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- Category I
- Category I
- Category I
- Category I
- Category I
- Category I
- Category I
- Category I
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INGREDIENTS AND APPEARANCE
CATEGORY I
immune system booster liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64616-082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT 6 [hp_X] in 1 mL ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E) ANAGALLIS ARVENSIS 6 [hp_X] in 1 mL ARGEMONE MEXICANA (UNII: 6X68976407) (ARGEMONE MEXICANA - UNII:6X68976407) ARGEMONE MEXICANA 15 [hp_X] in 1 mL CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 17 [hp_X] in 1 mL HELODERMA HORRIDUM VENOM (UNII: O9M1UQ4YIO) (HELODERMA HORRIDUM VENOM - UNII:O9M1UQ4YIO) HELODERMA HORRIDUM VENOM 14 [hp_X] in 1 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 5 [hp_X] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 10 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 10 [hp_X] in 1 mL POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 10 [hp_X] in 1 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 10 [hp_X] in 1 mL SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 7 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64616-082-02 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2013 Labeler - Vitality Works, Inc (137752817) Registrant - Vitality Works, Inc (137752817) Establishment Name Address ID/FEI Business Operations Vitality Works, Inc. 137752817 manufacture(64616-082)
