Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
Vitafol ® -OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Before, during and after pregnancy, one caplet daily, or as directed by a physician.
www.exeltisusa.comEach Caplet contains:
| VITAMINS AND MINERALS: | |||
|---|---|---|---|
| Vitamin A (as beta carotene) | 810 | mcg RAE | |
| Vitamin C (as ascorbic acid) | 70 | mg | |
| Vitamin D (as cholecalciferol) | 10 | mcg | |
Vitamin E (as dl-alpha tocopheryl acetate) | 13.5 | mg | |
Thiamin (Vitamin B1 as thiamine mononitrate) | 1.6 | mg | |
| Riboflavin (Vitamin B2) | 1.8 | mg | |
| Niacin (as niacinamide) | 18 | mg NE | |
| Vitamin B6 (as pyridoxine hydrochloride) | 2.5 | mg | |
| Folate (as folic acid) | 1700 | mg DFE | |
| Vitamin B12 (as cyanocobalamin) | 12 | mcg | |
| Calcium (as calcium carbonate) | 100 | mg | |
| Iron (as ferrous fumarate) | 65 | mg | |
| Magnesium (as magnesium oxide) | 25 | mg | |
| Zinc (as zinc oxide) | 25 | mg | |
| Copper (as copper oxide) | 2 | mg | |
Other Ingredients: microcrystalline cellulose, croscarmellose sodium, silicon dioxide, maltodextrin, copovidone, stearic acid, hydroxypropyl methylcellulose, dicalcium phosphate, acacia gum, titanium dioxide, polydextrose, starch, magnesium stearate, triacetin, modified food starch, mannitol, vitamin E alcohol, polyethylene glycol, talc, FD&C Blue #1, FD&C Blue #2.
Vitafol ®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Vitafol ®-OB is contraindicated in patients with hypersensitivity to any of its components or color additives.
Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.
Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12).
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.
Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.
The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.
Avoid Overdosage. Keep out of the reach of children.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.
Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.
Consult appropriate references for additional specific vitamin-drug interactions.
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Not for pediatric use.
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol ®-OB. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.
Before, during and after pregnancy, one caplet daily, or as directed by a physician.
Vitafol ®-OB is available as a light blue caplet, debossed EV0079. Available in Box of Unit-Dose pack of 100 (NDC 0642-0079-12) and as professional samples (0642-0079-03).
Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
| *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. |
Rx
Disributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2022 All rights reserved. Exeltis USA, Inc.
U.S. PATENT NO. 6,814,983; 7,390,509
Vitafol ® is a trademark of Exeltis Healthcare S.L.
Rev. December 2022 0791201-02
0642-0079-12
Vitafol
®-OB
Prenatal Supplement
10 X 10 UNIT DOSE PACK
100 CAPLETS
R x
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| COPPER Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NIACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| VITAMIN A Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
| cf050ccd-1144-f76a-e00d-e5698d8597d4 | Product name | 6 | 20250625 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0642-0079-03 | 2025-01-30 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2025-01-30 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-08 | 2022-12-31 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2022-12-31 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-08 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| 0642-0079-12 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a555-d8a0-e053-dadaa90a6e4e | Vitafol ® -OB Prenatal Supplement |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0642-0079-03 | Vitafol OBCaplet | 3 in 1 CARTON | TABLET | 3 | 6 | |
| 0642-0079-12 | Vitafol OBCaplet | 100 in 1 CARTON | TABLET | 100 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0642-0079 | VITAFOL OB CAPLET (VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, IRON, MAGNESIUM, ZINC, AND COPPER) TABLET [EXELTIS USA, INC.] | 6 | Legacy NDC, 2 package rows | 20230102_22828f24-600d-4aa6-9b3a-cf8c991f9a97.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0642-0079-12 | EA - Each | 0642-0079 | dc42a2ac-4a5b-4805-a23e-2d1a39417997 | 1 | 2014-10-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .Alpha.-Tocopherol | ACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Calcium | ACTIVE INGREDIENT | SY7Q814VUP | 1 | |
| Copper | ACTIVE INGREDIENT | 789U1901C5 | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Magnesium | ACTIVE INGREDIENT | I38ZP9992A | 1 | |
| Niacin | ACTIVE INGREDIENT | 2679MF687A | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| Thiamine Mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| Vitamin A | ACTIVE INGREDIENT | 81G40H8B0T | 1 | |
| Vitamin D | ACTIVE INGREDIENT | 9VU1KI44GP | 1 | |
| Zinc | ACTIVE INGREDIENT | J41CSQ7QDS | 1 | |
| .Alpha.-Tocopherol | ACTIVE MOIETY | H4N855PNZ1 | 1 | |
| Ascorbic Acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| Calcium | ACTIVE MOIETY | SY7Q814VUP | 1 | |
| Cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| Copper | ACTIVE MOIETY | 789U1901C5 | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Magnesium | ACTIVE MOIETY | I38ZP9992A | 1 | |
| Niacin | ACTIVE MOIETY | 2679MF687A | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| Thiamine Ion | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| Vitamin A | ACTIVE MOIETY | 81G40H8B0T | 1 | |
| Zinc | ACTIVE MOIETY | J41CSQ7QDS | 1 | |
| .Alpha.-Tocopherol, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 1 | |
| Acacia | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| Calcium Phosphate, Dibasic, Anhydrous | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Medium-Chain Triglycerides | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| Modified Corn Starch (1-Octenyl Succinic Anhydride) | INACTIVE INGREDIENT | 461P5CJN6T | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Ascorbate | INACTIVE INGREDIENT | S033EH8359 | 1 | |
| Sorbic Acid | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 1 | |
| Tricalcium Phosphate | INACTIVE INGREDIENT | K4C08XP666 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0642-0079 | 0642-0079-03, 0642-0079-12 |
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 |
|---|---|---|---|---|---|---|
| Acacia | ACACIA | 5C5403N26O | TABLET, COATED / ORAL | 156 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, DELAYED RELEASE / ORAL | 23 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| Sodium Ascorbate | SODIUM ASCORBATE | S033EH8359 | SUSPENSION, EXTENDED RELEASE / ORAL | 33 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET, EXTENDED RELEASE / ORAL | 0.37 mg | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Hydroxypropyl Cellulose (Type H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUPPOSITORY / RECTAL | 0.11 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | LOTION / TOPICAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| Calcium Phosphate, Dibasic, Anhydrous | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / BUCCAL | 60 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SHAMPOO / TOPICAL | NA | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| Hydroxypropyl Cellulose (Type H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | LOTION, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| Sodium Ascorbate | SODIUM ASCORBATE | S033EH8359 | INJECTION, SOLUTION / INTRAVENOUS | 29 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| Medium-Chain Triglycerides | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, COATED / ORAL | 2.5 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | 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 |
|---|---|---|---|---|---|---|
| f12aec60-46b4-6b23-e053-2995a90acb08 | 22828f24-600d-4aa6-9b3a-cf8c991f9a97 | 2022-12-31 | Boxed warning, Warnings, Adverse reactions | f12aec60-46b4-6b23-e053-2995a90acb08 22828f24-600d-4aa6-9b3a-cf8c991f9a97 |
Adverse event summaries are temporarily unavailable. Other product information remains available.