WestGel DHA

General Statements: All Other Content

69367-234-30 Rx

FDA Statement of Identity

Prenatal Supplement

Formulation re: Does NOT Contain

Sugar, gluten, lactose and dye free

Precautions re: Allergies

Contains soy and fish

Formulation re: Does NOT Contain

WestGel DHA softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners.

Formula re: Contains

WestGel DHA contains bovine gelatin.

Formula re: Type

Indications: WestGel DHA is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

Formulation re: Other

WestGel DHA can also be beneficial in improving the nutritional status of women prior to conception.

FDA Disclaimer Statement

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Precautions re: All Other

Contraindications: WestGel DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: Children

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.

Precautions re: Pregnant or Nursing or Prescription Medications

Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism. Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an Inherited or acquired predisposition to bleeding.

Precautions re: Allergies

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Precautions re: All Other

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294.

Suggested/Recommended/Usage/Directions

Directions: Adults: Take one softgel daily with or without food, or as prescribed by a healthcare practitioner. Children under 12: Consult a doctor. Do not exceed the recommended dose.

Formulation re: Other

How Supplied: WestGel DHA is available as oval, brown softgel capsules with a white imprint "WP234". A carton unit dose pack of 30 (3 child-resistant blister cards of 10 softgels each).

Storage

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F), excursions permitted to 15 degrees to 30 degrees C (59 degrees to 86 degrees F) [See USP Controlled Room Temperature.]

Precautions re: All Other

WestGel DHA should be administered only under the direct supervision of a healthcare practitioner. Avoid excessive heat, light and moisture.

Precautions re: Children

Keep out of reach of children.

Precautions re: All Other

Tamper Evident: Do not use if seal is broken or missing.

Precautions re: All Other

Precautions: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid is doses above 0.1 mg daily may obscure pernicious anemia that hematologic remission can occur while neurological manifestations progress. Ingestion of more than 3 grams of omega-3 fatty acids (such DHA and EPA) per day has been shown to have potential and antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR).