Multiple Vitamins (Adult) Pharmacy Bulk Package

openFDA label record#

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Brand name
Multiple Vitamins (Adult) Pharmacy Bulk Package
Generic name
ASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K, FOLIC ACID, BIOTIN, CYANOCOBALAMIN
Manufacturer
Apotex Corp.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
65701853-78f0-c3cc-1237-5595c59c1bd1
SPL ID
f32a72e0-e506-65d7-42aa-e620a5fa6665
Version
2
Effective date
2026-06-05
Source export date
2026-08-01
Applications, Product NDCs, Package NDCs table
ApplicationsProduct NDCsPackage NDCsRxCUIsUNIIsRoutes
ANDA21067260505-619160505-6191-0, 60505-6290-1, 60505-6291-2INTRAVENOUS

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) 5.1 Aluminum Toxicity Multiple vitamins injection (adult) contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of multiple vitamins injection (adult) in patients with renal impairment. 5.2 Allergic Reactions to Thiamine Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in multiple vitamins injection (adult). There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with multiple vitamins injection (adult) have been reported. 5.3. Hypervitaminosis A Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease, Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in multiple vitamins injection (adult), should be undertaken with caution [ see U...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other section of the labeling. • Allergic reactions to thiamine [ see Warnings and Precautions ( 5.2 ) ]. • Hypervitaminosis A [ see Warnings and Precautions ( 5.3 ) ] The following adverse reactions have been identified during postapproval use of multiple vitamins injection (adult). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch