C-NATE DHA- omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide capsule, gelatin coated

C-Nate DHA by

Drug Labeling and Warnings

C-Nate DHA by is a Prescription medication manufactured, distributed, or labeled by Centurion Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PRENATAL / MULTIVITAMIN

Rev. 10/12

Rx ONLY

Description:

DESCRIPTION

Each Softgel Contains:
Omega-3 Fatty Acids (DHA-EPA)	200mg
Vitamin B1 (Thiamine Mononitrate)	3 mg
Vitamin B2 (Riboflavin)	3 mg
Vitamin B6 (Pyridoxine HCL)	20 mg
Vitamin B12 (Cyanocobalamin)	15 mcg
Folic Acid	1 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin C (Ascorbic Acid)	100 mg
Vitamin E (d-alpha tocopherol)	30 IU
Copper (Cupric Sulfate)	1 mg
Zinc (Zinc Oxide)	20 mg
Iron (Fumerate)	28 mg
Magnesium	30 mg

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Gelatin, Glycerol, beeswax yellow, lecithin, water-purified and colorant.

INDICATIONS & USAGE

INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS

CONTRAINDICATIONS: C-NATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.

PRECAUTIONS

PRECAUTIONS: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PEDIATRIC USE

PEDIATRIC USE: Safety and effectiveness in pediactric patients has not been established.

GERIATRIC USE

GERIACTRIC USE: No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly person may have decreased hepatic, renal, or cardiac function.

DRUG INTERACTIONS

DRUG INTERACTIONS: C-NATE DHA softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

ADVERSE REACTIONS

ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Usual adult dose: one softgel daily or as prescribed by your doctor.

HOW SUPPLIED

HOW SUPPLIED: C-NATE DHA is available as a Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC #23359-105-30 and samples with NDC #23359-105-05 and NDC #23359-105-01.

PHYSICIAN SAMPLE NOT FOR RESALE

STORAGE AND HANDLING

Recommended Storage: 15°-30°C (59°-86°F) degrees. Protect from light moisture and avoid excessive heat. Dispense original carton.

KEEP OUT OF REACH OF CHILDREN

RX ONLY

SPL UNCLASSIFIED SECTION

CENTURION LABS, LLC
BIRMINGHAM, AL 35243

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 23359-105-30

C-Nate
DHA

Softgels
Omega-3 Fatty Acids (DHA-EPA)	200mg
Vitamin B1 (Thiamine Mononitrate)	3 mg
Vitamin B2 (Riboflavin)	3 mg
Vitamin B6 (Pyridoxine HCL)	20 mg
Vitamin B12 (Cyanocobalamin)	15 mcg
Folic Acid	1 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin C (Ascorbic Acid)	100 mg
Vitamin E (d-alpha tocopherol)	30 IU
Copper (Cupric Sulfate)	1 mg
Zinc (Zinc Oxide)	20 mg
Iron (Fumerate)	28 mg
Magnesium	30 mg

Rx Only

Net Contents: 30 softgels

Manufactured For:
Centurion Labs LLC

Distributed by:
Centurion Labs LLC
Birmingham, AL 35243

INGREDIENTS AND APPEARANCE

C-NATE DHA 
omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 23359-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3 FATTY ACIDS	200 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	15 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	30 [iU]
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	28 mg
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A)	MAGNESIUM	30 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN (annato)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PRE;01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23359-105-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2013
2	NDC: 23359-105-05	5 in 1 CARTON; Type 0: Not a Combination Product	01/10/2013
3	NDC: 23359-105-01	1 in 1 PACKET; Type 0: Not a Combination Product	01/10/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2013

Labeler - Centurion Labs, LLC (016481957)

Registrant - Centurion Labs, LLC (016481957)