WesNatal DHA Complete
STATEMENT OF IDENTITY SECTION
Multivitamin/Multimineral Tablet
Omega-3 Fatty Acid Capsule
Other Ingredients: Tablets: Microcrystalline Cellulose, Croscarmellose Sodium, Tripotassium Citrate, Coating (Sodium Carboxymethylcellulose, Dextrin, Dextrose, Lecithin, Sodium Citrate), Acacia, Citric Acid, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid.
Soft gelatin capsules: Bovine Gelatin, Glycerin, Water, and Ethyl Vanillin.
THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVIES & SARDINES).
WesNatal DHA Complete is a multivitamin/multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.
| Vitamin A (as Beta-Carotene) | 900 mcg RAE (3000 IU) | 69% |
| Vitamin C (Abscorbic Acid) | 120 mg | 100% |
| Vitamin D (as Cholecalciferol) | 10 mcg (400 IU) | 67% |
| Vitamin E (as dl-Alpha Tocopheryl Acetate) | 15 mg30 mg dl-Alpha Tocopheryl Acetate equivalent to 15 mg Alpha-Tocopherol | 79% |
| Thiamin (as Thiamine Mononitrate) | 1.8 mg | 129% |
| Riboflavin | 4 mg | 250% |
| Niacin (as Niacinamide) | 20 mg NE | 111% |
| Vitamin B6 (as Pyridoxine HCl) | 25 mg | 1250% |
| Folate | 1667 mcg DFE(1000 mcg Folic Acid) | 278% |
| Vitamin B12 (as Cyanocobalamin) | 12 mcg | 429% |
| Calcium (as Calcium Carbonate) | 200 mg | 15% |
| Iron (from Ferrous Bisglycinate and Iron Protein Succinylate) | 29 mg | 107% |
| Magnesium (as Magnesium Oxide) | 25 mg | 6% |
| Zinc (as Zinc Oxide) | 25 mg | 192% |
| Copper (as Cupric Oxide) | 2 mg | 154% |
| DHA (Docosahexaenoic Acid) | 200 mg | Daily Value (DV) not established |
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 oil.
WARNINGS
Administration of ometa-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
PRECAUTIONS
General
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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Safety and effectiveness in elderly populations have not been established.
DRUG INTERACTIONS
WesNatal DHA Complete is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).
WARNINGS SECTION
| 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. |
ADVERSE REACTIONS
Adverse reactions with iron therapy are usually transient and may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain.
DESCRIPTION
WesNatal Complete tablets are clear coated, speckled light brown, oval tablets with debossed "251" on one side. WesNatal DHA Complete soft gelatin capsules are oblong, clear transparent soft gel capsules containing a pale yellow oil/liquid.
DIRECTIONS FOR USE
Take one tablet and one soft gelatin capsule by mouth daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day.
HOW SUPPLIED
WesNatal DHA Complete 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: 69367-251-30
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.
HEALTH CLAIM SECTION
KEEP OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for:Westminster Pharmaceuticals, LLCNashville, TN 37217Made in Canada
500392Rev. 02/23