CATEGORY I- immune system booster liquid

Category I by

Drug Labeling and Warnings

Category I by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc, Vitality Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CATEGORY I 
immune system booster liquid

Product 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)