Complete Natal DHA

TRIGEN Laboratories, Inc.

Complete Natal DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• COMPLETE NATAL DHA DESCRIPTION
• COMPLETE NATAL DHA INDICATIONS AND USAGE
• COMPLETE NATAL DHA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Drug Interactions
  • Pediatric Use
  • Geriatric Use
• COMPLETE NATAL DHA ADVERSE REACTIONS
• COMPLETE NATAL DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

COMPLETE NATAL DHA DESCRIPTION

Complete Natal DHA is a prescription prenatal multivitamin/ multimineral and omega-3 fatty acid supplement supplied as tablets and soft gelatin capsules for oral administration. The tablets are oval, light brown and yellow speckled, film-coated tablets, debossed "01030". The capsules are pale yellow soft gelatin capsules.

Inactive Ingredients: Tablets: microcrystalline cellulose, tripotassium citrate, croscarmellose sodium, hypromellose, acacia, citric acid, povidone K30, fumed silica, magnesium stearate, polyethylene glycol, stearic acid, polysorbate 80, vegetable oil. Soft gelatin capsules: gelatin, glycerin, purified water, vitamin E, ethyl vanillin.

THIS PRODUCT CONTAINS SOY.

COMPLETE NATAL DHA INDICATIONS AND USAGE

Complete Natal DHA is a multivitamin/multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Complete Natal DHA is also useful is also useful in improving the nutritional status of women prior to conception.

COMPLETE NATAL DHA CONTRAINDICATIONS

Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson's disease. This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.

The FDA has not required that Complete Natal DHA be approved for therapeutic equivalence or rated for therapeutic equivalence. It is not the subject of an FDA approval. Even when products are labeled as containing the same active ingredients, they may have minor differences, such as the source of ingredients, different potency specifications or different inactive ingredients. State law governs the substitution of prescription pharmaceuticals.

WARNINGS

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 remain progressive. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA)] from fish oilsmay have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding, diatheses, including those taking anticoagulants.

PRECAUTIONS

General

The calcium content should be considered before prescribing for patients with kidney stones. Don not exceed recommended dose.

Drug Interactions

Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

COMPLETE NATAL DHA ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

COMPLETE NATAL DHA DOSAGE AND ADMINISTRATION

Take before, during and after pregnancy, one tablet and one soft gelatin capsule daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

HOW SUPPLIED

Complete Natal DHA is supplied in a 30-day unit-of-use dispensing carton containing 6 blister cards of 5 tablets and 5 soft gelatin capsules each.

PRODUCT CODE 13811-010-30.

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP controlled room temperature.] Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).

KEEP OUT OF REACH OF CHILDREN.

Manufactured for:
TRIGEN Laboratories
Sayreville, NJ 08872

REV. 02/13

PRINCIPAL DISPLAY PANEL - Kit Carton

TRIGEN
LABORATORIES

13811-010-30

Complete Natal DHA

Prenatal Multivitamin/Multimineral
Tablets and Omega-3 Fatty Acid
Soft Gelatin Capsules

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.

30 Tablets and
30 Soft Gelatin Capsules

(6 Unit-Dose Cards of
5 tablets and
5 soft gelatin capsules)

R_x Only