Folbee Plus By Breckenridge Pharmaceutical Overview & Drug Interactions

Check For Interactions With Folbee Plus

Supplement: Folbee Plus by Breckenridge Pharmaceutical

Folbee Plus Label Images

This product contains

Below is a list of the 'active' ingredients listed on the supplement label for this product.

For a list of 'other ingredients', such as fillers, please see the 'Label Information' section on this page.

Drugs that interact with Folbee Plus by Breckenridge Pharmaceutical

Below is a list of drug interactions for each ingredient in this supplement product. Please note that a supplement product may contain more than one ingredient that has interactions.

Label Information

Supplement Facts:

Daily Value (DV) Target Group(s): Adults and children 4 or more years of age
Minimum serving Sizes:
1 Tablet(s)
Maximum serving Sizes:
1 Tablet(s)
UPC/BARCODE 351991082903

Ingredient Amount per Serving Group % DV, Adults & children 4+ years
Folic Acid
5 mg
Vitamin B9 (folic acid)
Vitamin B12
1 mg
Vitamin B12
Vitamin B1
1.5 mg
Thiamin
Vitamin B2
1.5 mg
Riboflavin
Vitamin B6
50 mg
Vitamin B6
Vitamin B3
20 mg
Niacin
Vitamin C
60 mg
Vitamin C
Pantothenic Acid
10 mg
Pantothenic Acid
D-Biotin
300 mcg
Biotin

Other Ingredients:
Dicalcium Phosphate
Microcrystalline Cellulose
Croscarmellose Sodium
Hypromellose
Stearic Acid
Titanium Dioxide
Sodium Lauryl Sulfate
Magnesium Silicate
Triacetin
Magnesium Stearate
Mineral Oil


Label Statments:


Suggested/Recommended/Usage/Directions
- Dosage and administration: Usual adult dosage is one tablet daily, between meals, or as directed by a physician or health-care provider. For dialysis patients, Folbee Plus should be taken daily. On dialysis days, Folbee Plus Tablets should be taken after dialysis treatment.
- Forbee Plus Tablets are labeled as a medical food intended for use under active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food.
Precautions
- If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
- Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
- To report a serious adverse event contact: 1-800-367-3395.
- Do not use this product if the inner safety seal under the cap is torn, broken or missing.
- This product is recommended for use under the supervision of a physician, or health-care provider.
- Contraindications: Known hypersensitivity to any of the components in the products is a contraindication.
- Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
- Do not exceed recommended dosage. Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Folbee Plus Tablets.
- Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine hcl. Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling or swelling of entire body has been associated with cyanocobalamin.
- Drug interactions: Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparations containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.
- Patient information: Folbee Plus Tablets are for use only under the direction and supervision of a licensed physician or health-care provider.
FDA Disclaimer Statement
- 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.
Brand IP Statement(s)
- Some or all of the following patents may apply: U.S. Patent No. 4,940,658; U.S. Patent No. 5,563,126; U.S. Patent No. 5,795,873; U.S.Patent No. 6,207,651; U.S. Patent No. 6,297,224; U.S. Patent No. 6,528,496 and other pending patent applications.
General Statements
- All substitutions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.
- Medical food
- How supplied Folbee Plus Tablets are available as a yellow, film-coated, capsule-shaped tablet, debossed "B 082" in bottles or 90 tablets, 51991-082-90.
Formulation
- Sugar and lactose free
Storage
- Store at 25(0)C (77(0)F); excursions permitted to 15(0)-30(0)C (59(0)-86(0)F). See USP controlled room temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
Formula
- Indications and usage: For the dietary management of individuals with distinct nutritional needs under a physician or health-care provider's supervision for end stage renal failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.
- Medical foods: Medical foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of a normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription.
- Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Folbee Plus Tablets.

Brand Information

See all products by this brand

Distributed by
Name Breckenridge Pharmaceutical, Inc.
City Boca Raton
State FL
ZipCode 33487
Manufactured by
Name Contract Pharmacal Corp.
City Hauppauge
State NY
ZipCode 11788

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Parts of this content are provided by the Therapeutic Research Center, LLC and the Dietary Supplement Label Database.

DISCLAIMER: Currently this does not check for drug-drug interactions. This is not an all-inclusive comprehensive list of potential interactions and is for informational purposes only. Not all interactions are known or well-reported in the scientific literature, and new interactions are continually being reported. Input is needed from a qualified healthcare provider including a pharmacist before starting any therapy. Application of clinical judgment is necessary.

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Drug descriptions are provided by MedlinePlus.