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Abavite

Package insert / prescribing information
Generic name: methylcobalamin, ascorbic acid, niacin, magnesium oxide, vitamin a palmitate, zinc oxide, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, cholecalciferol, ferrous sulfate, calcium pantothenate, potassium iodide and riboflavin
Dosage form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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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

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

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

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.

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).

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

Not for pediatric use. Keep out of reach of Children

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

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:73397-311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 0.5 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
NIACIN (NIACIN) NIACIN 15 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 0.33 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 13.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.6 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 0.025 mg
FERROUS SULFATE (FERROUS CATION) FERROUS CATION 30 mg
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 5 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 0.25 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.8 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM CITRATE
HYPROMELLOSE 2910 (10000 MPA.S)
STEARIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
GLYCERIN
SILICON DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 10mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:73397-311-30 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/31/2021
Labeler - ABACOS HEALTH (117194224)
ABACOS HEALTH