Folbic Tablets are indicated for the distrinct nutritional requirements of individuals under a physician's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atheroscierotic vascular disease in the coronary, peripheral, or cerebral vessels, or vitamin B12 dificiency.
Usual adult dose is one to two tablets daily or as directed by a physician.
Each rose colored tablet contains the following active ingredients: Folacin (Folic Acid) 2.5 mg, Pyridoxine (B6) 25mg, Cyanocobalamin (B12) 2mg, Folbic Tablets do not contain sugar or lactose.
Inactive Ingredients: Carmine, Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Riboflavin, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.
Folbic Tablets are indicated for the distrinct nutritional requirements of individuals under a physician's supervision for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atheroscierotic vascular disease in the coronary, peripheral, or cerebral vessels, or vitamin B12 dificiency.
Known hypersensitivity to any of the components in the product is a contraindication.
KEEP THIS AND ALL MEDICATIO OUT OF THE REACH OF CHILDREN IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
All prescription substitutions using this product ahall be pursuant ot state statutes as applicable. This is not an Orange Book Product.
Folacin (folic acid) when administered as a single agent in doses above 0.1 mg daily may obscure pemicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 2mgs of cyanocobalamin contained in Folbic Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75 yrs) to have the potential to reduce natural killer cells' cytotoxicity, which may result in an impaired immune response.
Cyanocobalamin should not be used in those with Leber's optic atrophy. Decreased levels of B12 have been associated with reduced ability to detoxify the cyanide in exposed individuals and cyanocobalamin may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B12 is an acceptable form for B12 supplementation in those with this disorder.
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 recieving a a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.
Pregnant women and nursing mothers should only use 12 microgram doses of B12 (cyanocobalamin) from nutritional supplements. Doses higher than this should only be recommended by your physician. Administration of doses of vitamin B12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.
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.
Allergic sensitization has been reported following both oral an dparental administration of folacin (folic acid). Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemis vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.
Usual adult dose is one to two tablets daily or as directed by a physician.
Folbic Tablets are available as an oval, rose colored tablet, debossed B 384. Supplied in blisterpacks of 30 tablets, NDC# 0615-7575-39.
Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees 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.
Rx Only
Manufacitred by: Contract Pharmacal Corp. Hauppauge, NY 11788
Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487
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.
References:
Elkelboom JW, Lonn Eva, Genest Jr Jaques, Hankey Graeme, Yusuf Salim: Homocysteine and Cardiovascular Disease: A Critical Review of the Epidemiologic Evidence. Ann Intern Med. 1999; 131:363-375.
The Homocysteine Studies Collaboration: Homocysteine and Risk of Ischemic Heart Disease and Stroke, JAMA 2002; Vol 288, No 16:2015-2002.
Refusum Helga, Smith A. David: Ueland Per M. Nexo Ebba, Clarke Robert, McPartlin Joseph, Johnston Carole, Engbaek Frode, Schneede Jorn, McPartlin Catherine, and Scott John M: Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion. Clinical Chemisty 2004; 50:1 3-32.
Kuzminski AM, Del Giacco EJ, Aften RH, et ai: Effective Treatment of Cobalamin Defiiency with oral Cobalamin. Blood 1998; 92:1191-1198.
Troen AM, Mitchell B. Sorensen B. Wener MH, Hohnston A, Wood B. Selhub J. McTiernan A, Yasui Y, Oral E, Potter JD, and Ulrich CM, Unmetabolized Folic Acid in Plasma ia Associated with Reduced Natural Killer Cell Cytotoxicity among Postmenopausal Women. Jounal of Nutrition 2006 Jan; 136 (1): 189-194.
Folbic Tabs 2.5mg/25mg/2mg
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0615-7575-39 | 2021-05-22 | C162847 | 48780-1 | 960f7f55-d274-8e05-e053-dbdaa90a074a | Folbic Tablet |
| 0615-7575-39 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d274-8e05-e053-dbdaa90a074a | Folbic Tablet |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 6 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 6 | |
| PYRIDOXINE | ACTIVE INGREDIENT | KV2JZ1BI6Z | 6 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 6 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 6 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 6 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | 6 | |
| CARMINIC ACID | INACTIVE INGREDIENT | CID8Z8N95N | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 6 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 6 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 6 | |
| RIBOFLAVIN | INACTIVE INGREDIENT | TLM2976OFR | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0615-7575 | 0615-7575-39 |
| 51991-384 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, DELAYED RELEASE / ORAL | 23 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | CAPSULE / ORAL | 40 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | CONCENTRATE / ORAL | 250 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET / SUBLINGUAL | 1.2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, COATED / ORAL | 123 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / SUBLINGUAL | 28 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, EXTENDED RELEASE / ORAL | 26 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SUSPENSION / ORAL | 7 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | CAPSULE / ORAL | 401 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, EXTENDED RELEASE / ORAL | 360 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / BUCCAL | 60 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 842120b6-35a7-4a93-8483-864c9023a8c4 | 99121923-2b2d-427a-865a-e8b7dd052569 | 2021-05-18 | Warnings, Adverse reactions | 99121923-2b2d-427a-865a-e8b7dd052569 |
Adverse event summaries are temporarily unavailable. Other product information remains available.