Category : HUMAN PRESCRIPTION DRUG LABEL DEA Schedule : none Marketing Status : New Drug Application INGREDIENTS AND APPEARANCE LABELER - Hikma Pharmaceuticals USA Inc.(001230762) PRINCIPAL DISPLAY PANEL NDC 0143-9621-01 1 mL Vial Cyanocobalamin Injection, USP Rx only 1,000 mcg/mL For IM or SC use ONLY Protect from light Contains Benzyl Alcohol NDC 0143-9621-25 Rx only Cyanocobalamin Injection, USP 1,000 mcg/mL For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 25 x 1 mL Vials PRINCIPAL DISPLAY PANEL NDC 0143-9620-01 10 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143-9620-10 Rx only Cyanocobalamin Injection, USP 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 10 mL Multiple Dose Vials PRINCIPAL DISPLAY PANEL NDC 0143-9619-01 30 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143-9619-10 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 30 mL Multiple Dose Vials NDC 0143-9619-01 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 1 x 30 mL Multiple Dose Vials PRINCIPAL DISPLAY PANEL
If you use the treatment period to establish these sustainable habits, you are much more likely to maintain your results long after the therapy ends
In off-label use the safety and efficacy for that specific use have not been established by the FDA.
They will also set an upper limit on the total weekly dose (for example, some experts recommend not exceeding approximately 300 mg per week in subcutaneous dosing without further evaluation) to minimize any risk of adverse effects
