Label: DAVIMET WITH IRON- iron, folate tablet
- NDC Code(s): 59088-160-54
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated June 3, 2024
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DESCRIPTION:
Each caplet contains:
Vitamin A (as Retinyl Acetate).......................................750 mcg RAE
Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)........ 60 mg
Vitamin D3 (as Cholecalciferol)................................. 10 mcg (400 IU)
Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 6.75 mg
Thiamin (as Thiamine Mononitrate)....................................... 1.05 mg
Riboflavin................................................................................. 1.2 mg
Niacin (as Niacinamide).......................................................... 13.5 mg
Vitamin B6 (as Pyridoxine Hydrochloride)............................. 1.05 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE
(1000 mcg as L-5-Methylfolate)
Vitamin B12 (as Methylcobalamin)......................................... 4.5 mcg
Iron (as Iron Amino Acid Chelate)............................................... 11 mg
Other Ingredients: Aspartame, CI 15985 / [Yellow 6 Lake], Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural OrangeFlavor, Stearic Acid (Vegetable Source), Sucrose.Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.
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INDICATIONS AND USAGE:
Davimet™ with Iron Multivitamin Chewable Tablets are indicated for the treatment of iron deficiency anemia and folate deficiency, commonly seen in conditionssuch as extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. They are also indicated for condition in which irondeficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as casesof metabolic stress, and in convalescence.
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CONTRAINDICATIONS:
This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients withhemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
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WARNING:
Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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 accidentaloverdose, call a doctor or poison control center immediately.
Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.
CAUTION: Should be chewed.PRECAUTIONS:
Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviatingthe hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before thecorrect diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Use only under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions:
Davimet™ with Iron Multivitamin Chewable Tablets are not recommended and should not be given to patients receiving levodopa because the action oflevodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin orClopidogrel).
Adverse Reactions:
Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate.
Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy.Although the absorption of iron is best when taken between meals, giving Davimet™ with Iron Multivitamin Chewable Tablets after meals may controloccasional gastrointestinal disturbances. Davimet™ with Iron Multivitamin Chewable Tablets is best absorbed when taken at bedtime.
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergicand idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in somepatients -
OVERDOSE:
Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Othersymptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Whenoverdoses are ingested by children, severe reactions, including fatalities, have resulted. Davimet™ with Iron Multivitamin Chewable Tablets should be stored beyond the reach of children to prevent against accidental iron poisoning.
- DOSAGE AND ADMINISTRATION:
- STORAGE AND HANDLING
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HOW SUPPLIED:
Davimet™ with Iron Multivitamin Chewable Tablets are light orange with speckles, orange flavor, un-scored, round tablets. Available on prescription only in bottleof 30 tablets – NDC 59088-160-54. Dispense in a tight, light resistant container with a child resistant closure as defined in the USP/NF. All prescription substitutionsusing this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
- Davimet™ with Iron
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INGREDIENTS AND APPEARANCE
DAVIMET WITH IRON
iron, folate tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 750 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 24 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 13.5 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.05 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 11 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 4.5 ug SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 36 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1000 ug .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 6.75 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange (Light Orange with Speckles) Score no score Shape ROUND Size 13mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-160-54 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/03/2024 Labeler - PureTek Corporation (785961046)
