FDA Label for C-nate Dha
View Indications, Usage & Precautions
C-nate Dha Product Label
The following document was submitted to the FDA by the labeler of this product Centurion Labs, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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 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
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
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