CitraNatal B-Calm
Generic Name: ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid
Dosage Form: tablet
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.
CitraNatal B-Calm®
Rx Prenatal Vitamin and two 25 mg each B6 tablets
A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B6 which may act as an antiemetic.
CitraNatal B-Calm Description
CitraNatal B-Calm® is a prescription prenatal multivitamin/mineral tablet with B6, along with two vitamin B6 tablets. 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 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) | 120 mg |
| Iron (Carbonyl iron, Ferrous gluconate) | 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 |
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
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Warning
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
PRECAUTION
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CitraNatal B-Calm 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.
How is CitraNatal B-Calm Supplied
Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B6 tablets each - NDC 0178-0832-30.
To report a serious adverse event or obtain product information, call (210) 696-8400.
50310 C01 Rev 008110
Ferr-Ease®
Dual-iron delivery
Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
missionpharmacal.com
Copyright © 2011 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.
PRINCIPAL DISPLAY PANEL - Blister Pack Carton
Rx Only
NDC 0178-0832-30
The gentle option for
additional B6
CitraNatalB-Calm®
Rx Prenatal Vitamin and two 25 mg each Vitamin B6 tablets
A prescription
prenatal supplement
with 1 mg of folic
acid and a high level
of vitamin B6 which
may act as an
antiemetic.
march of dimes®
Mission Pharmacal is a proud
supporter of the March of Dimes.*
Mission®
PHARMACAL
CONTAINS
Six 5-day Blister Packs
| CitraNatal B-Calm ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit |
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| Labeler - Mission Pharmacal Company (008117095) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mission Pharmacal Company | 927726893 | MANUFACTURE(0178-0832) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nutra-Med Packaging, Inc. | 022004902 | PACK(0178-0832) | |
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