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 
Centurion Labs, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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C-Nate DHA

PRENATAL / MULTIVITAMIN

Rev. 10/12

Rx ONLY

Description:

Each Softgel Contains:
Omega-3 Fatty Acids (DHA-EPA)200mg
Vitamin B 1 (Thiamine Mononitrate) 3 mg
Vitamin B 2 (Riboflavin) 3 mg
Vitamin B6 (Pyridoxine HCL)20 mg
Vitamin B 12 (Cyanocobalamin) 15 mcg
Folic Acid1 mg
Vitamin D 3 (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
Magnesium30 mg

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

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

PRECAUTIONS: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.

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

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

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

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

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 B 1 (Thiamine Mononitrate) 3 mg
Vitamin B 2 (Riboflavin) 3 mg
Vitamin B 6 (Pyridoxine HCL) 20 mg
Vitamin B 12 (Cyanocobalamin) 15 mcg
Folic Acid1 mg
Vitamin D 3 (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
Magnesium30 mg

Rx Only

Net Contents: 30 softgels

Manufactured For:
Centurion Labs LLC

Distributed by:
Centurion Labs LLC
Birmingham, AL 35243

PRINCIPAL DISPLAY PANEL - 30 tablets
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23359-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS200 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 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 CATION1 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 mg
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM30 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (annato) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PRE;01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23359-105-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
2NDC:23359-105-055 in 1 CARTON; Type 0: Not a Combination Product01/01/2013
3NDC:23359-105-011 in 1 PACKET; Type 0: Not a Combination Product01/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2013
Labeler - Centurion Labs, LLC (016481957)

Revised: 1/2024
Document Id: 0cf3fb03-9078-9d79-e063-6394a90a3ae1
Set id: 8c1b2367-cec5-4a18-82a0-e132b4aece3a
Version: 5
Effective Time: 20240122
 
Centurion Labs, LLC