Folic Acid (Page 2 of 2)

OVERDOSAGE

Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B12 deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.

DOSAGE AND ADMINISTRATION

Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.

The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily. Resistant cases may require larger doses.

When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.

In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

HOW SUPPLIED

Folic Acid Tablets, USP 1 mg are light yellow, round, scored, debossed “3162” on one side and debossed “V” on the reverse side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1004-1 1 MG 30 Tablets in a Blister Pack light yellow 0603-3162

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

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1004 1mg

Label Image for 1mgLabel Image for 1mg
FOLIC ACID
folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-1004(NDC:0603-3162)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 3162;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-1004-1 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040756 11/01/2014
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-1004)

Revised: 01/2015 State of Florida DOH Central Pharmacy

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