Generic Name: folic acid
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

FaLessa™
Folate 1 mg Tablets

with Quatrefolic
Fourth Generation Folate

RX ONLY

DESCRIPTION:

FaLessa™ with Quatrefolic®, Fourth Generation folate is a round, light blue tablet imprinted with a Q.

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ACTIVE INGREDIENTS

Folate 1 mg (as 1.85 mg Quatrefolic® ((6S)-5,-methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 1 mg of Folic acid)

INACTIVE INGREDIENTS

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Blue #1, FD&C Blue #2, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Titanium Dioxide, Triacetin.

INDICATIONS

FaLessa™ folate tablets are a folic acid supplement indicated to be beneficial in improving the nutritional status of women prior to conception and throughout pregnancy.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients contained herein.

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

How is FaLessa Supplied

Each carton contains unit-dose packs of 56 tablets (NDC 75854-601-01).

STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS # 1181972-37-1

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022

1-888-61-AVION

Rev. 0915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unit-dose packs of 56 tablets       75854-601-01

FaLessa™
Folate Tablets
1 mg

with
Quatrefolic
Fourth Generation Folate

Rx Only

Avion
PHARMACEUTICALS

FaLessa 
folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-601
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
CROSCARMELLOSE SODIUM  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code Q
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-601-01 56 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/15/2014
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 09/2014
 
Avion Pharmaceuticals, LLC
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