- General Statements: All Other Content
- RX Only
- FDA Statement of Identity
- Dietary Supplement
- Formula re: Contains
- Description: FeRiva 21/7 tablets for oral administration is a 28-day iron supplement regiment that consists of 21 red, oval-shaped iron tablets and 7 purple, oval-shaped inert tablets. Each red, oval-shaped iron tablet is debossed with "21" and "7" separated by a line in the middle on the top-side of the tablet and blank on the other side. Each purple, oval shaped inert tablet is blank on both sides of the tablet.
- Formulation re: Does NOT Contain
- Purple Inert Tablets do not contain any vitamins, minerals or other dietary ingredients. Please see other ingredients section below for the listing of the inert ingredients.
- Formulation re: Other
- Indications: FeRiva 21/7 is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
- Precautions re: All Other
- Contraindications: FeRiva 21/7 is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.
- Precautions re: Children
- 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.
- FDA Disclaimer Statement
- These statements have 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
- 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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
- Precautions re: Pregnant or Nursing or Prescription Medications
- While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered.
- Precautions re: Allergies
- Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
- Suggested/Recommended/Usage/Directions
- Dosage and Administration: Usual dosage is one tablet daily with or without food or as prescribed by your healthcare provider. The FeRiva 21/7 Tablets blister pack supplies a 28-day course of iron therapy that consists of 21 red iron tablets and 7 purple inert tablets. Take 1 red iron tablet daily for 21 days, followed by 1 purple inert tablet daily for 7 days. After 28 tablets have been taken a new course maybe started if prescribed.
- General Statements: All Other Content
- How Supplied: FeRiva 21/7 tablets blister pack (75854+318-28) contains 21 red iron tablets and 7 purple inert tablets. The listed product number is not a National Drug Code. Instead Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.
- Precautions re: Children
- Keep out of reach of children.
- Storage
- Store betweed 20 degrees - 25 degrees C (68 degrees - 77 degrees F).
- Brand IP Statement(s) re: (c), (TM), (SM)
- Sumalate is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846, and 8,425,956.