C-Nate DHA

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

PRENATAL / MULTIVITAMIN

Rev. 10/12

Rx ONLY

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 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 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.

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 B1 (Thiamine Mononitrate)3 mg
Vitamin B2 (Riboflavin)3 mg
Vitamin B6 (Pyridoxine HCL)20 mg
Vitamin B12 (Cyanocobalamin)15 mcg
Folic Acid1 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
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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 200 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 1 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 20 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 28 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 30 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
GLYCERIN
YELLOW WAX
LECITHIN, SOYBEAN
WATER
Product Characteristics
Color BROWN (annato) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PRE;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23359-105-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
2 NDC:23359-105-05 5 CAPSULE, GELATIN COATED in 1 CARTON None
3 NDC:23359-105-01 1 CAPSULE, GELATIN COATED in 1 PACKET None
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)

Revised: 12/2019 Centurion Labs, LLC

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