Dialyvite Supreme D

Name: Dialyvite Supreme D

Precautions

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.


Keep out of reach of children.

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NDC 10542-009-09

Dialyvite Supreme D

Multivitamin Supplement for Dialysis Patients

90 Tablets



Dialyvite Supreme D 
ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, zinc, selenium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10542-009
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 100 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 2000 [iU]
.alpha.-tocopherol succinate, d- (.alpha.-tocopherol, d-) .alpha.-tocopherol, d- 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.5 mg
Riboflavin (Riboflavin) Riboflavin 1.7 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 3 mg
Cobalamin (Cobalamin) Cobalamin 1 mg
Biotin (Biotin) Biotin 300 ug
Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid 10 mg
Zinc Citrate (Zinc Cation) Zinc Cation 15 mg
Selenocysteine (Selenium) Selenium 70 ug
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Croscarmellose Sodium  
Glyceryl Monostearate  
Shellac  
Starch, Corn  
Silicon Dioxide  
Calcium Stearate  
Sodium Copper Chlorophyllin  
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code H
Contains     
Packaging
# Item Code Package Description
1 NDC:10542-009-09 90 TABLET, COATED in 1 BOTTLE, PLASTIC
2 NDC:10542-009-02 7 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/08/2010
Labeler - Hillestad Pharmaceuticals USA (029291085)
Establishment
Name Address ID/FEI Operations
Hillestad Pharmaceuticals USA 029291085 manufacture(10542-009), label(10542-009)
Revised: 12/2015   Hillestad Pharmaceuticals USA

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • Very hard stools (constipation).
  • Muscle weakness.
  • Numbness and tingling.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Dialyvite Supreme D may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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