Label: CITRANATAL BLOOM DHA- iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0178-0816-30 - Packager: Mission Pharmacal Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 6, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
CitraNatal Bloom™ DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other. The essential fatty acid DHA soft gel is oblong, light brown and contains a yellow to orange fill.
Each prenatal tablet contains:
Iron (Carbonyl iron, ferrous gluconate)...........................90 mg
Folic Acid .........................................................................1 mg
Vitamin B12 (Cyanocobalamin) ...................................12 mcg
Vitamin C (Ascorbic acid).............................................120 mg
Docusate sodium ..........................................................50 mg
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS AND PRECAUTIONS
WARNING: 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.
WARNING: 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 B12 is deficient.
PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
Please consult your health care provider with any dietary concerns.
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
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STORAGE AND HANDLING
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be
tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE: Contact with moisture can discolor or erode the tablet.
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (800) 298-1087.
MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355
51080R0717
MISSION ® PHARMACAL
DHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Copyright © 2017 Mission Pharmacal Company.
All rights reserved.
www.missionpharmacal.comFerr-Ease ®
Dual-iron deliveryTrademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
life's DHA ®
life’sDHA is a trademark of DSM.
U.S. Patent No. 7,579,174
U.S. Patent No. 7,732,170
U.S. Patent No. 5,518,918
*March of Dimes does not endorse
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation. - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITRANATAL BLOOM DHA
iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0816 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0816-30 30 in 1 CARTON 01/18/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 1 of 2 PRENATAL
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 1.5 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 88.5 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM SILICATE (UNII: 9B9691B2N9) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ETHYL VANILLIN (UNII: YC9ST449YJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color green (Coated Tablet) Score score with uneven pieces Shape RECTANGLE (Modified Rectangle) Size 9mm Flavor Imprint Code CB;blank Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/22/2018 Part 2 of 2 DHA
dha capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRYPTHECODINIUM COHNII DHA OIL (UNII: 8ZJ335A17J) (CRYPTHECODINIUM COHNII DHA OIL - UNII:8ZJ335A17J) CRYPTHECODINIUM COHNII DHA OIL 300 mg in 300 mg Inactive Ingredients Ingredient Name Strength ICOSAPENT (UNII: AAN7QOV9EA) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) ASCORBYL PALMITATE (UNII: QN83US2B0N) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color brown (Soft gelatin capsule) Score no score Shape CAPSULE (Soft gelatin capsule) Size 23mm Flavor Imprint Code none Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/18/2018 Labeler - Mission Pharmacal Company (008117095) Registrant - Mission Pharmacal Company (922772689) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 manufacture(0178-0816)