COENZYME COMPOSITUM- beta vulgaris and ascorbic acid and cysteine and magnesium orotate and manganese phosphate, dibasic and sodium diethyl oxalacetate and niacinamide and pulsatilla vulgaris and pyridoxine hydrochloride and riboflavin and thiamine hydrochloride and .alpha.-lipoic acid and .alpha.-ketoglutaric acid and cerous oxalate nonahydrate and aconitic acid, (z)- and anhydrous citric acid and coenzyme a and fumaric acid and malic acid and nadide and sodium pyruvate and succinic acid tablet
Heel 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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Coenzyme Compositum Tablet

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

For the relief of:

Exhaustion
Fatigue
Feelings of low energy

WARNINGS

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

Adults and children above 6 years: 1 tablet sublingually or dissolved completely in mouth 3 times daily or as directed by a physician. Infants and children to 6 years: 1/2 the adult dosage.

ACTIVE INGREDIENT

Each 300 mg tablet contains as active ingredients: Beta vulgaris 4X, Ascorbicum acidum 6X, Cysteinum 6X, Magnesium oroticum 6X, Manganum phosphoricum 6X, Natrum oxalaceticum 6X, Nicotinamidum 6X, Pulsatilla 6X, Pyridoxinum hydrochloricum 6X, Riboflavinum 6X, Thiaminum hydrochloricum 6X, a-Lipoicum acidum 6X, a-Ketoglutaricum acidum 8X, Cerium oxalicum 8X, cis-Aconiticum acidum 8X, Citricum acidum 8X, Coenzyme A 8X, Fumaricum acidum 8X, Malicum acidum 8X, Nadidum 8X, Natrum pyruvicum 8X, Succinicum acidum 8X ATP 10X, Baryta oxalsuccinicum 10X Hepar sulphuris calcareum 10X, Sulphur 10X 3mg each.

INACTIVE INGREDIENT

Lactose, Magnesium stearate

PURPOSE

Exhaustion, Fatigue, Feelings of low energy

COENZYME COMPOSITUM
beta vulgaris and ascorbic acid and cysteine and magnesium orotate and manganese phosphate, dibasic and sodium diethyl oxalacetate and niacinamide and pulsatilla vulgaris and pyridoxine hydrochloride and riboflavin and thiamine hydrochloride and .alpha.-lipoic acid and .alpha.-ketoglutaric acid and cerous oxalate nonahydrate and aconitic acid, (z)- and anhydrous citric acid and coenzyme a and fumaric acid and malic acid and nadide and sodium pyruvate and succinic acid tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50114-6141
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051)	BETA VULGARIS	4 [hp_X]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	6 [hp_X]
CYSTEINE (UNII: K848JZ4886) (CYSTEINE - UNII:K848JZ4886)	CYSTEINE	6 [hp_X]
MAGNESIUM OROTATE (UNII: GI96W46M5A) (MAGNESIUM OROTATE - UNII:GI96W46M5A)	MAGNESIUM OROTATE	6 [hp_X]
MANGANESE PHOSPHATE, DIBASIC (UNII: VZ3U1H7Q5B) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE PHOSPHATE, DIBASIC	6 [hp_X]
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7)	SODIUM DIETHYL OXALACETATE	6 [hp_X]
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	6 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	6 [hp_X]
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	6 [hp_X]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	6 [hp_X]
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y)	.ALPHA.-LIPOIC ACID	6 [hp_X]
.ALPHA.-KETOGLUTARIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	.ALPHA.-KETOGLUTARIC ACID	8 [hp_X]
CEROUS OXALATE NONAHYDRATE (UNII: 0UV74P3R0J) (CEROUS CATION - UNII:72Q4U60JWI)	CEROUS OXALATE NONAHYDRATE	8 [hp_X]
ACONITIC ACID, (Z)- (UNII: OF5471ZHRR) (ACONITIC ACID, (Z)- - UNII:OF5471ZHRR)	ACONITIC ACID, (Z)-	8 [hp_X]
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	8 [hp_X]
COENZYME A (UNII: SAA04E81UX) (COENZYME A - UNII:SAA04E81UX)	COENZYME A	8 [hp_X]
FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131)	FUMARIC ACID	8 [hp_X]
MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP)	MALIC ACID	8 [hp_X]
NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK)	NADIDE	8 [hp_X]
SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR)	SODIUM PYRUVATE	8 [hp_X]
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L)	SUCCINIC ACID	8 [hp_X]
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE	10 [hp_X]
BARIUM OXALOSUCCINATE (UNII: L7A49804ZQ) (BARIUM CATION - UNII:V645272HLN)	BARIUM OXALOSUCCINATE	10 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	10 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Tablet)	Size	9mm
Flavor		Imprint Code	Heel
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-6141-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2003	04/30/2014
2	NDC:50114-6141-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2003	04/30/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/31/2003	04/30/2014

Labeler - Heel Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Heel Inc		102783016	manufacture(50114-6141)

Revised: 5/2018

Document Id: e17b029e-9254-4543-a4df-8353012439c4

Set id: d596d156-7425-40ab-83d0-022d591e66f9

Version: 2

Effective Time: 20180522

Heel Inc