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 poison control center immediately.
One capsule daily or as directed by a physician. Store at controlled room temperature. NOTICE Contact with moisture can discolor or erode the capsule.
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 poison control center immediately.
CitraNatal Harmony ® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed “0797” in white ink.
| Each prenatal capsule contains: | |||
| Calcium (Calcium citrate) | 104 mg | Vitamin B 6 (Pyridoxine HCI) | 25 mg |
| Iron (Carbonyl iron) | 29 mg | Folic Acid | 1 mg |
| Vitamin D 3 (Cholecalciferol) | 400 |U | Docusate Sodium | 50 mg |
| Vitamin E (d|-alpha tocopheryl acetate) | 30 |U | Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) | 265 mg |
CitraNatal Harmony ® is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
This product is contraindictated in patients with a known hypersensitivity to any of the ingredients.
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
WARNING
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CAUTION
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
One capsule daily or as directed by a physician.
Store at controlled room temperature.
NOTICE
Contact with moisture can discolor or erode the capsule.
Bottles of 30 capsules each — NDC 0178–0797–30
To report a serious adverse event or obtain product information, call (210) 696–8400
Please consult your health care provider with any dietary concerns.
Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
CitraNatal Sample Carton
NDC 0178-0797-06
CitraNatal Label
NDC 0178-0797-05
CitraNatal Starter Pack
CitraNatal Label
NDC 0178-0797-30
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0178-0797-05 | Citranatal Harmony 2.1 | 5 in 1 BOTTLE | CAPSULE, GELATIN COATED | 5 | 3 | |
| 0178-0797-05 | Citranatal Harmony 2.1 | 1 in 1 CARTON | CAPSULE, GELATIN COATED | 1 | 3 | |
| 0178-0797-30 | Citranatal Harmony 2.1 | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0178-0797 | CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY] | 3 | Legacy NDC, 3 package rows | 20190515_00ecf076-d840-bee7-38d1-48bae1066bff.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0178-0797-30 | EA - Each | 0178-0797 | e6832705-013a-4d53-bd99-1565601c56d6 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CALCIUM CITRATE | ACTIVE INGREDIENT | MLM29U2X85 | 1 | |
| IRON | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| IRON | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| CHOLECALCIFEROL | INACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| DOCONEXENT | INACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| FOLIC ACID | INACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| PYRIDOXINE | INACTIVE INGREDIENT | KV2JZ1BI6Z | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0178-0797 | 0178-0797-05, 0178-0797-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHOLECALCIFEROL | 1C6V77QF41 | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| PYRIDOXINE | KV2JZ1BI6Z | IACT |
| FOLIC ACID | 935E97BOY8 | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| DOCONEXENT | ZAD9OKH9JC | IACT |
| CALCIUM CITRATE | MLM29U2X85 | ACTIR |
| IRON | E1UOL152H7 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET, FILM COATED / ORAL | 6 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.64 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.77 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | CAPSULE / ORAL | 8.2 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SHAMPOO / TOPICAL | 2 %w/w | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET, COATED / ORAL | 1 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | INJECTION / INTRAMUSCULAR | 0.02 %w/v | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | GEL / TOPICAL | 6 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 20 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SUSPENSION / ORAL | 48 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET / ORAL | 50 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg |
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 |
|---|---|---|---|---|---|---|
| 88dc0784-2854-b47f-e053-2a95a90ac51a | 00ecf076-d840-bee7-38d1-48bae1066bff | 2019-05-14 | Boxed warning, Warnings, Adverse reactions | 88dc0784-2854-b47f-e053-2a95a90ac51a 00ecf076-d840-bee7-38d1-48bae1066bff |
Adverse event summaries are temporarily unavailable. Other product information remains available.