FolaWise

Manufacturer
Redmont Pharmaceuticals, LLC
Effective date
2025-06-23
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:46

Label at a glance#

ProductFolaWise
Active ingredientBeta Carotene, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, PYRIDOXINE HYDROCHLORIDE, Folic Acid, LEVOMEFOLATE CALCIUM, Cyanocobalamin
Label structure14 sections

Dosage and administration

One tablet daily directed by a physician.

Storage and handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do not use if seal if broken or missing.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

71741-406-30
Multivitamin Dietary Supplement
Dispensed by Prescription

DESCRIPTION

HEALTH CLAIM SECTION

FolaWise is a prescription multivitamin dietary supplement.

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving size: 1 Tablet
Amount per Serving:%Daily Value
Vitamin A (as Beta-Carotene)300 mcg RAE33%
Vitamin C (as Ascorbic Acid)90 mg100%
Vitamin D3 (as Cholecalciferol)20 mcg100%
Vitamin E (as dl-Alpha Tocopherol Acetate)4.5 mg (10 IU)30%
Thiamin1.2 mg100%
Riboflavin1.3 mg100%
Vitamin B6 (as Pyridoxine HCl)26 mg1529%  
Folate1.67 mg DFE418%  
  (from Folic Acid)0.67 mg DFE
  (as 5-Methyl Tetrahydrofolate Calcium Salt)1 mg DFE
Vitamin B12 (as Cyanocobalamin)13 mcg542%

OTHER INGREDIENTS: Modified Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, Polyethylene Glycol.

Preservative Free and Gluten Free. No sugar, starch, artificial colors, artificial flavors, wheat, yeast or corn added.

INDICATIONS

HEALTH CLAIM SECTION

FolaWise is a prescription multivitamin that provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, thiamine mononitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

FolaWise is contraindicated in patients with a known hypersensitivity to any the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

PRECAUTIONS

PRECAUTIONS SECTION

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. FolaWise should only be used under the direction and supervision of a licensed medical practitioner.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling Redmont Pharmaceuticals, LLC at 1-800-986-5909.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One tablet daily directed by a physician.

HOW SUPPLIED

HEALTH CLAIM SECTION

Bottles of 30 tablets (71741-406-301). Tablet is white, round.

  1. Federal Register Notice of August 2, 1973 (38 FR20750)
  2. Federal Register Notice of October 17, 1980 (45 FR69043, 69044)
  3. Federal Register Notice of March 5, 1996 (61FR 8760

1 Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies. This product is a prescriptionfolate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indications or claims of this product are not to be construed to be drug claims.

STORAGE AND HANDLING

HEALTH CLAIM SECTION

STORAGE

HEALTH CLAIM SECTION

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

[See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.

TAMPER EVIDENT: Do not use if seal if broken or missing.

HEALTH CLAIM SECTION

MADE IN THE USA

Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

SAFE HANDLING WARNING SECTION

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

HEALTH CLAIM SECTION

© 2025 Redmont Pharmaceuticals, LLC
406111-0625

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71741-406-30

FolaWise

DIETARY SUPPLEMENT

30 TABLETS

Dispensed by Prescription

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71741-406-30FolaWise30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71741-406-30EA - Each71741-4066fa490d7-46f4-43cd-a11e-42f4e6b21c3612025-07-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71741-40671741-406-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.