Label: CORVITA 150- iron, folic acid, ascorbic acid, pyridoxine hydrochloride, cyanocobalamin and citrate tablet
- NHRIC Code(s): 13811-066-10
- Packager: Trigen Laboratories, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated December 23, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SUPPLEMENT FACTS
Other Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Red Color Coating (Polyvinyl Alcohol, Polyethylene Glycol, FD&C Red #40 Lake, Talc, Titanium Dioxide), Croscarmellose Sodium, Magnesium Stearate, Stearic Acid
GLUTEN-, LACTOSE- AND SUGAR-FREE
CORVITA™ 150 is a prescription multivitamin/multimineral supplement used to improve the nutritional status of patients with iron deficiency - CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITA™150. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Folic Acid: Folic acid alone is an 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 neurologic 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 populations have not been established.
Geriatric Use: Safety and effectiveness in elderly populations have not been established.
- DRUG INTERACTIONS
- ADVERSE REACTIONS
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OVERDOSAGE
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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HEALTH CLAIM
KEEP THIS PRODUCT 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 Trigen Laboratories at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-CORVITA150-00001-1 Rev. 12/2021
Manufactured for:
Trigen Laboratories, LLC
Alpharetta, GA 30005www.trigenlab.com
- PRINCIPAL DISPLAY PANEL - 100 Tablets Blister Label
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INGREDIENTS AND APPEARANCE
CORVITA 150
iron, folic acid, ascorbic acid, pyridoxine hydrochloride, cyanocobalamin and citrate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-066 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 150 mg Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic Acid 1.25 mg ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid 120 mg pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride 10 mg Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin 15 ug ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 25 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C RED NO. 40 (UNII: WZB9127XOA) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:13811-066-10 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 07/13/2013 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color imprint scoring 2 shape size (solid drugs) 19 mm Labeler - Trigen Laboratories, LLC (830479668)