CATEGORY IV- 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 IV

Category IV

Actaea Spicata 6X                                    Dulcamara 5X

Aloe Socotrina 7X                                     Fraxinus Americana 8X

Cantharis 7X                                            La Defloratum 12X, 20X

Cuprum Arsenicosum 15X                        Urtica Urens 5X

Cuprum Metallicum 10X                           Zinc Metallicum 10X, 20X

Category IV

Alcohol, Purified Water

Category IV

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

Category IV

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

Category IV

For the temporary relief of headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

Category IV

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

Category IV

Temporarly relieves headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

Category IV

Label

CATEGORY IV 
immune system booster liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-085
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
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE7 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA7 [hp_X]  in 1 mL
CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ARSENITE15 [hp_X]  in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER10 [hp_X]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP5 [hp_X]  in 1 mL
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK20 [hp_X]  in 1 mL
FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK8 [hp_X]  in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS5 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC20 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64616-085-0259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/20/2013
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(64616-085)

Revised: 12/2023
Document Id: 0d9ba1fe-019b-4c6a-e063-6294a90a641a
Set id: 790a1b3e-2b5e-426c-9c43-8674c59c9ce1
Version: 7
Effective Time: 20231228
 
Vitality Works, Inc.