Label: CITRANATAL B-CALM- ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit
- NDC Code(s): 0178-0832-30
- Packager: Mission Pharmacal Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 8, 2024
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DESCRIPTION
CitraNatal B-Calm ®is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6tablets. The prenatal tablet contains Ferr-Ease ®, a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with "0832" on one side and is blank on the other. The B 625 mg tablets are white to off-white, uncoated, round, and are debossed with "B" on one side and "6" on the other.
Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 120 mg Iron (Carbonyl iron, Ferrous gluconate) 20 mg Vitamin D 3(Cholecalciferol) 400 IU Vitamin B 6(Pyridoxine HCl) 25 mg Folic Acid 1 mg Each vitamin B 6tablet contains: Vitamin B 6(Pyridoxine HCl) 25 mg -
INDICATIONS
CitraNatal B-Calm ®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. CitraNatal B-Calm ®may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.
- CONTRAINDICATIONS
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- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
To reporta serious adverse event or obtain product information, call (210) 696-8400.
50310 C01 Rev 0820
Mission ®
PHARMACALDHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355www.missionpharmacal.com
Copyright © 2020 Mission Pharmacal Company.
All rights reserved.
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INGREDIENTS AND APPEARANCE
CITRANATAL B-CALM
ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0832 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0832-30 6 in 1 CARTON 06/18/2012 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 BLISTER PACK 30 Part 2 6 BLISTER PACK 60 Part 1 of 2 PRENATAL VITAMIN
ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS 120 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 20 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) 174.3 mg CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 55 mg POVIDONE (UNII: FZ989GH94E) 30 mg HYPROMELLOSES (UNII: 3NXW29V3WO) 18.9 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) 17.5 mg MAGNESIUM SILICATE (UNII: 9B9691B2N9) 9 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 2.2 mg VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.25 mg DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code 0832 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/18/2012 Part 2 of 2 VITAMIN B6
pyridoxine hydrochloride tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code B;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/18/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/18/2012 Labeler - Mission Pharmacal Company (008117095) Establishment Name Address ID/FEI Business Operations Nutra-Med Packaging, Inc. 022004902 pack(0178-0832) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 manufacture(0178-0832)