Label: CITRANATAL B-CALM- ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid
- NDC Code(s): 0178-0866-30
- Packager: Mission Pharmacal Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated May 3, 2010
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- BOXED WARNING(What is this?)
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.Close
- SPL UNCLASSIFIED SECTION
A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B6 which may act as an antiemetic.Close
CitraNatal® B-Calm™ is a prescription prenatal multivitamin/mineral tablet with a high level of B6, along with two vitamin B6 tablets. The prenatal tablet is white, coated, modified oval, and is debossed with "0866" on one side and is blank on the other. The B6 25 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) 125 mg Iron (Carbonyl iron) 20 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin B6 (Pyridoxine HCl) 25 mg Folic Acid 1 mg
Each vitamin B6 tablet contains:
Vitamin B6 (Pyridoxine HCl) 25 mg
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.Close
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.Close
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.Close
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.Close
- ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
- DOSAGE AND ADMINISTRATION
One tablet every eight hours, beginning with "Tablet 1", or as directed by a physician.
Store at controlled room temperature.
NOTICE: Contact with moisture can discolor or erode tablets.Close
- HOW SUPPLIED
Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B6 tablets each - NDC 0178-0866-30.
To report a serious adverse event or obtain product information, call (210) 696-8400.Close
- SPL UNCLASSIFIED SECTION
50307 C01 REV 010090
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Copyright © 2009 Mission Pharmacal Company.
All rights reserved.
*March of Dimes does not endorse specific products or brands. March of dimes is a registered trademark of the March of Dimes Foundation.Close
- PRINCIPAL DISPLAY PANEL
The gentle option for
Rx Prenatal Vitamin with two 25 mg each Vitamin B6 tablets
with 1 mg of folic
acid and a high level
of vitamin B6 which
may act as an
march of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.®
Six 5-day Blister Packs
- INGREDIENTS AND APPEARANCE
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0866 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0178-0866-30 5 in 1 CARTON 1 1 in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 Part 2 10 Part 1 of 2 PRENATAL VITAMIN
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid tablet, coated
Product 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 calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate 125 mg Iron Pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron Pentacarbonyl - UNII:6WQ62TAQ6Z) Iron Pentacarbonyl 20 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid 1 mg Inactive Ingredients Ingredient Name Strength Polyethylene Glycol (UNII: 3WJQ0SDW1A) Cellulose, Microcrystalline (UNII: OP1R32D61U) Povidone (UNII: FZ989GH94E) Hypromelloses (UNII: 3NXW29V3WO) Titanium Dioxide (UNII: 15FIX9V2JP) Magnesium Silicate (UNII: 9B9691B2N9) Magnesium Stearate (UNII: 70097M6I30) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Product Characteristics Color WHITE Score no score Shape OVAL (modified) Size 19mm Flavor Imprint Code 0866 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/10/2010 Part 2 of 2 VITAMIN B6
pyridoxine hydrochloride tablet
Product 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 Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) Povidone (UNII: FZ989GH94E) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color WHITE (off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code B;6 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 02/10/2010 Labeler - Mission Pharmacal Company (008117095) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 MANUFACTURE Establishment Name Address ID/FEI Business Operations Nutra-Med Packaging Inc. 022004902 PACK