CATEGORY I- immune system booster liquid 
Vitality Works, Inc

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.

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Category I

Category I

Actaea Spicata 6X                           Kali Bichromicum 6X, 10X

Anagallis Arvensis 6X                      Kali Iodatum 8X, 10X

Argemone Mexicana 15X                 Kali Nitricum 8X, 10X

Candida Albicans 14X, 17X              Kali Phosphoricum 8X, 10X

Heloderma 14X                               Senna 7X

Hyoscyamus Niger 5X                     Spongia Tosta 10X, 15X

Category I

Alcohol, Purified Water,

Category I

Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missing.

Category I

Keep out of reach of children. In case of overdose, get medical help or contact aPoison Control Center right away.

Category I

For the temporary relief of general systemic malise, flu and cold symptoms and achiness.

Category I

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult.

Category I

Temporarily eases malaise, flu and cold symptoms and aches.

Category I

Label

CATEGORY I 
immune system booster liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-082
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT6 [hp_X]  in 1 mL
ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E) ANAGALLIS ARVENSIS6 [hp_X]  in 1 mL
ARGEMONE MEXICANA (UNII: 6X68976407) (ARGEMONE MEXICANA - UNII:6X68976407) ARGEMONE MEXICANA15 [hp_X]  in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS17 [hp_X]  in 1 mL
HELODERMA HORRIDUM VENOM (UNII: O9M1UQ4YIO) (HELODERMA HORRIDUM VENOM - UNII:O9M1UQ4YIO) HELODERMA HORRIDUM VENOM14 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER5 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE10 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION10 [hp_X]  in 1 mL
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE10 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 1 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF7 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64616-082-0259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/16/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/20/2013
Labeler - Vitality Works, Inc (137752817)
Registrant - Vitality Works, Inc (137752817)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works, Inc.137752817manufacture(64616-082)

Revised: 12/2023
Document Id: 0d9b708d-7035-1072-e063-6394a90a7f2c
Set id: 1cbb330b-b541-457b-9a97-e17a5837d30d
Version: 9
Effective Time: 20231228
 
Vitality Works, Inc