C-nate Dha
FDA Label NDC 23359-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Centurion Labs, Llc for the product C-nate Dha (NDC 23359-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, inactive ingredient, indications & usage, contraindications, precautions, warnings, pediatric use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

PRENATAL / MULTIVITAMIN

Rev. 10/12

Rx ONLY

CENTURION LABS, LLC
BIRMINGHAM, AL 35243

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 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

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

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)

Principal Display Panel (30 tablets)

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