Folic Acid Injection

Name: Folic Acid Injection

Uses of Folic Acid Injection

  • It is used to help with some kinds of anemia.
  • This vitamin is used to aid the diet needs before, during, and after pregnancy.
  • It may be given to you for other reasons. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Clinical pharmacology

In man, an exogenous source of folate is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells and platelets in persons suffering from certain megaloblastic anemias.

How supplied

Folic Acid Injection, USP 50 mg per 10 mL (5 mg per mL)  is available as:

Product      No.
NDC                                       No.

18410
63323-184-10                 
50 mg per 10 mL (5 mg per mL), 10 mL Multiple Dose, in a flip-top vial packaged individually.
18411
63323-184-11                  
50 mg per 10 mL (5 mg per mL), 10 mL Multiple Dose, in a flip-top vial, 10 vials per tray.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

PROTECT FROM LIGHT.

Retain vial in carton until contents are used.



www.fresenius-kabi.us

45842G

Revised: November 2016


PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Label

Folic Acid Injection, USP

50 mg per 10 mL (5 mg/mL)

For intramuscular, intravenous or subcutaneous use.

10 mL Multiple Dose Vial 
Rx only



 

PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Carton Label

Folic Acid Injection, USP

50 mg per 10 mL (5 mg per mL)

For intramuscular, intravenous or subcutaneous use.

10 mL Multiple Dose Vial

Rx only


FOLIC ACID 
Folic Acid Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-184
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE SODIUM 2 mg  in 1 mL
BENZYL ALCOHOL 15 mg  in 1 mL
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:63323-184-10 1 VIAL, MULTI-DOSE in 1 CARTON
1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089202 09/05/2000
Labeler - Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 MANUFACTURE(63323-184)
Revised: 01/2017   Fresenius Kabi USA, LLC

Precautions

Before using folic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, vitamin B12 deficiency (pernicious anemia).

This product may contain aluminum, which can rarely build up to dangerous levels in the body. The risk may be increased if this product is used for an extended time, especially in people with kidney disease. Tell your doctor right away if you notice any symptoms of too much aluminum in the body such as muscle weakness, bone pain, or mental changes.

Folic acid is safe to take during pregnancy when used as directed. Certain spinal cord birth defects may be prevented by maintaining adequate amounts of folic acid during pregnancy. Consult your doctor for more details.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: chloramphenicol, methotrexate.

Folic acid may affect certain laboratory tests for vitamin B12 deficiency, resulting in false test results. Untreated vitamin B12 deficiency may result in serious nerve problems (e.g., peripheral neuropathy with numbness/tingling symptoms). Consult your doctor or pharmacist for details.

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