discover FaLessa Generic Name: folic acid Dosage Form: tablet Side Effects Dosage Professional Interactions Pregnancy More User Reviews Support Group Q & A 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 Slideshow Looking Ahead: New Drug Approvals for 2017 DESCRIPTION: FaLessa with Quatrefolic , Fourth Generation folate is a round, light blue tablet imprinted with a Q. 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 Next Interactions Print this page Add to My Med List More about FaLessa (folic acid) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Consumer resources Professional resources Folic Acid (AHFS Monograph) Folic Acid Injection (FDA) FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC A Pregnancy Category Studies show no risk N/A CSA Schedule Not a controlled drug Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More FaLessa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! lately
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