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 5/16″, scored, round, yellow to orange color tablets imprinted “EP 127” and supplied in bottles of 100 (NDC 64125-127-01) and 1000 (NDC 64125-127-10).

Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F).

Manufactured by:

Excellium Pharmaceutical, Inc.

3 G Oak Road, Fairfield, NJ 07004

ISS 07/07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXCELLIUM

NDC 64125-127-01

FOLIC ACID TABLETS, USP

1 mg

Rx only

100 Tablets

folic acid 1mg 100tabs
(click image for full-size original)

EXCELLIUM

NDC 64125-127-10

FOLIC ACID TABLETS, USP

1 mg

Rx only

1000 Tablets

folic acid 1mg 1000tabs
(click image for full-size original)
FOLIC ACID
folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64125-127
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP;127
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64125-127-01 100 TABLET (TABLET) in 1 BOTTLE None
2 NDC:64125-127-10 1000 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040796 06/01/2009
Labeler — Excellium Pharmaceutical Inc. (011769192)
Establishment
Name Address ID/FEI Operations
Excellium Pharmaceutical Inc. 011769192 MANUFACTURE (64125-127)

Revised: 08/2012 Excellium Pharmaceutical Inc.

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