Label: ABAVITE- vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, pantothenic acid, iron, iodine, magnesium, zinc. tablet

  • 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 October 6, 2021

If you are a consumer or patient please visit this version.

  • COMPONENTS

    ]

    Name of Ingredient

    Amount per serving

    % Daily Value

    Vitamin A (Palmitate [1100IU]

    330 mcg

    37%

    Vitamin C (as ascorbic acid)

    60 mg

    67%

    Vitamin D (as cholecalciferol [400IU])

    25 mcg

    125%

    Vitamin E (as dl-alpha tocopheryl acetate [30IU])

    13.5 mg

    90%

    Thiamine (vitamin B1) (as thiamine mononitrate)

    1.6 mg

    133%

    Riboflavin (vitamin B2)

    1.8 mg

    138%

    Niacin (as niacinamide)

    15 mg

    94%

    Vitamin B6 (as pyridoxine hydrochloride)

    10 mg

    588%

    Folate

    1667 mcg DFE

    (1000 mcg folic acid)

    417%

    Vitamin B12 (as methylcobalamin)

    500 mcg

    20833%

    Pantothenic acid (as d-calcium pantothenate)

    5 mg

    100%

    Iron (as ferrous sulfate)

    30 mg

    167%

    Iodine (as potassium iodide)

    250 mcg

    167%

    Magnesium (as magnesium oxide)

    25 mg

    6%

    Zinc (as zinc oxide)

    15 mg

    136%

    Other inactive Ingredients:

    Other Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, SodiumCitrate, Silicon Dioxide, Magnesium Stearate, Clear Vegetable Coating: Hypromellose, Glycerine

  • INDICATIONS & USAGE

    ABAVITE is a supplement indicated to provide vitamin, mineral supplementation to support optimum vitamin levels.

  • DOSAGE & ADMINISTRATION

    The usual adult dose is 1 tablet once or twice daily or as instructed by a licensed medical practitioner. If you are pregnant or nursing,ask a healthcare professional Dosage abd Administration

  • WARNINGS

    Vitamin D therapy should be cautiously used in patients with hyperparathyroidism (or any condition which may lead directly or indirectly to hypercalcemia), hypercalcemia, or people who have renal stones or at risk of having renal stones. High doses of vitamin D may elevate levels of calcium, which may eventually accumulate in the blood and soft tissues. Bone pain, high blood pressure, the formation of kidney stones, renal failure, and increased risk of heart disease can also occur.

    Prolonged use of iron supplements may lead to iron storage disease.

    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.

    High Dose Folic acid supplementation may conceal an occult vitamin B 12 deficiency and further exacerbate or initiate neurologic disease. Therefore, clinicians should consider ruling out vitamin B 12 deficiency before initiating folic acid therapy.

    Do NOT use Abavite if you have an allergy for one or more components listed above.

    Possible interactions:

    High doses of folic acid may result in reduced serum levels of anticonvulsant drugs.

    Vitamin D supplementation should be avoided in hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones (Calcium oxalate stones).

    Consult your physician or pharmacist for additional information regarding vitamin-drug interactions.

  • CONTRAINDICATIONS

    ABAVITE is Contraindicated in patients with known or documented hypersensitivity to any of its listed ingredients or color additives. Folic acid is a contraindication in patients with untreated and uncomplicated pernicious anemia and those with an anaphylactic allergy to folic acid. Iron therapy is a contraindication in patients with hemochromatosis or Potential or current disease, which involves iron storage due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis), red cell enzyme deficiencies, etc.); pyridoxine responsive anemia, or cirrhosis of the liver. Methylcobalamin is a contraindication in patients with sensitivity to cobalt or methylcobalamin (Vitamin B-12).

  • PREGNANCY

    If you're pregnant or nursing mother you should ask your healthcare practitioner before use.

  • PEDIATRIC USE

    Not for pediatric use. Keep out of reach of Children

  • STORAGE AND HANDLING

    The usual adult dose is 1 tablet once or twice daily or as instructed by a licensed medical practitioner. If you are pregnant or nursing,
    ask a healthcare professional

  • Prencible Display Panel

    Prencible Display Panel

  • INGREDIENTS AND APPEARANCE
    ABAVITE 
    vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, pantothenic acid, iron, iodine, magnesium, zinc. tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73397-311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN0.5 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN15 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A0.33 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-13.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.6 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.025 mg
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.25 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73397-311-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/31/2021
    Labeler - ABACOS HEALTH (117194224)