Adults: One caplet twice daily, or as directed by a physician. UDAMIN SP is not recommended for women or adolescents. Supplement Facts Serving Size 1 Caplet Servings Per Container 100 Each White, Film-coated Capsule Shaped Tablet (caplet) for Oral Administration Contains) Vitamin E (as d-alpha tocopheryl acid succinate from soy) ..............75 IU Vitamin B6 (as pyridoxine HCL) .....................................
UDAMIN SP caplets for oral administration is a 90-day dietary supplement that consists of 100 white film-coated, capsule shaped tablet each debossed with “PE820”.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Adults: One caplet twice daily, or as directed by a physician. UDAMIN SP is not recommended for women or adolescents.
| Supplement Facts |
| Serving Size 1 Caplet Servings Per Container 100 |
| Each White, Film-coated Capsule Shaped Tablet (caplet) for Oral Administration Contains) |
| Vitamin E |
| (as d-alpha tocopheryl acid succinate from soy) ..............75 IU |
| Vitamin B6 |
| (as pyridoxine HCL) ......................................................12.5 mg |
| Folic Acid ................................................................... 1000 mcg |
| Vitamin B12 |
| (as cyanocobalamin) ....................................................250 mcg |
| Zinc |
| (as zinc gluconate) .........................................................7.5 mg |
| Selenium |
| (as selenium chelate) ...................................................100 mcg |
| Saw Palmetto Extract ...................................................320 mg* |
| Other tocopherols: |
| (d-gamma, d-delta, d-beta) ..............................................17 mg |
| Lycopene Complex ..........................................................2.5 mg |
| *Yielding 144 mg of active ingredients, including free fatty acids. |
OTHER INGREDIENTS: Each caplet also contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate, cellulose, calcium silicate, rice protein, partially pregelatinized maize starch, silica, stearic acid, maltodextrin, sodium croscarmellose, magnesium stearate, gelatin (poultry), sucrose, corn starch, sodium selenite, ascorbyl palmitate, sodium ascorbate, Dl-alpha tocopherol. Coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc.
HOW SUPPLIED: White film-coated, capsule shaped tablet—supplied in bottles of 100. Debossed with “PE820”. Store at controlled room temperature between 15°-30°C (59°-86°F).
Dispense in a tight, light resistant container as defined in the USP/NF with a child-resistant closure. NDC#50991-0231-01, 100 caplets per bottle. The listed product number is not a National Drug Code. Instead, Poly Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.
Folic acids in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 250 mcg of Vitamin B12 (as cyanocobalamin) contained in each caplet of UDAMIN SP should address this precaution.
Adverse Reactions
Allergic sensitization has been reported following both oral and parental administration of folic acid. Paresthesia, somnolence have been reported with pyridoxine HCl.
Drug Interactions
Pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.
STORAGE: Store controlled room temperature, 15°- 30°C (59°- 86°F)
Because toxic reactions have been reported with injudicious use of certain vitamins and minerals, patients should be instructed to follow physician’s dosage regimen.
ALLERGEN STATEMENT: This product contains soy.
CONTRAINDICATIONS: UDAMIN SP is contraindicated in patients with a known hypersensitivity to any of its ingredients.
– 100 Caplets container label
50991-231-01 RX ONLY
Udamin SP
DIETARY SUPPLEMENT
Manufactured For:
Poly Pharmaceuticals, Inc
Mobile, AL 36119
Protected by U.S. Patent #'s 7,002,350;7,186,421; and 7,390,511
Revised 07/11 8838
| Class | Version | Type | Effective |
|---|---|---|---|
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 86fffa7b-d382-4771-a253-25cccb64b590 | Product name | 3 | 20251124 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50991-231-01 | UDAMIN SP | 100 in 1 BOTTLE | CAPSULE, COATED | 100 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50991-231 | UDAMIN SP (VITAMIN E, VITAMIN B6, FOLIC ACID, VITAMIN B12, ZINC, SELENIUM, SAW PALMETTO, TOCOPHEROLS AND LYCOPENE COMPLEX) CAPSULE, COATED [POLY PHARMACEUTICALS, INC.] | 3 | 1 package rows | 20150520_8a995199-e1f0-492d-988f-78dfba5810a4.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50991-231-01 | EA - Each | 50991-231 | bfd9b078-148d-4080-81a6-7e0a8fa653bd | 1 | 2015-06-09 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL | ACTIVE INGREDIENT | H4N855PNZ1 | 3 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 3 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 3 | |
| LYCOPENE | ACTIVE INGREDIENT | SB0N2N0WV6 | 3 | |
| PYRIDOXINE | ACTIVE INGREDIENT | KV2JZ1BI6Z | 3 | |
| SAW PALMETTO | ACTIVE INGREDIENT | J7WWH9M8QS | 3 | |
| SELENIUM | ACTIVE INGREDIENT | H6241UJ22B | 3 | |
| TOCOPHEROL | ACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| ZINC | ACTIVE INGREDIENT | J41CSQ7QDS | 3 | |
| .ALPHA.-TOCOPHEROL | ACTIVE MOIETY | H4N855PNZ1 | 3 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 3 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 3 | |
| LYCOPENE | ACTIVE MOIETY | SB0N2N0WV6 | 3 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 3 | |
| SAW PALMETTO | ACTIVE MOIETY | J7WWH9M8QS | 3 | |
| SELENIUM | ACTIVE MOIETY | H6241UJ22B | 3 | |
| TOCOPHEROL | ACTIVE MOIETY | R0ZB2556P8 | 3 | |
| ZINC | ACTIVE MOIETY | J41CSQ7QDS | 3 | |
| .ALPHA.-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 3 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 3 | |
| CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUS | INACTIVE INGREDIENT | 701EKV9RMN | 3 | |
| CALCIUM SILICATE | INACTIVE INGREDIENT | S4255P4G5M | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 3 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM ASCORBATE | INACTIVE INGREDIENT | S033EH8359 | 3 | |
| SODIUM SELENITE | INACTIVE INGREDIENT | HIW548RQ3W | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50991-231 | 50991-231-01 |
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 |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | POWDER, FOR SUSPENSION / ORAL | 1600 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | PASTE / ORAL | 1050 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| GELATIN | GELATIN | 2G86QN327L | ELIXIR / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| POWDERED CELLULOSE | POWDERED CELLULOSE | SMD1X3XO9M | TABLET, EXTENDED RELEASE / ORAL | 156 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg |
Adverse event summaries are temporarily unavailable. Other product information remains available.