FDA Label for Citranatal B-calm
View Indications, Usage & Precautions
Citranatal B-calm Product Label
The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B6 which may act as an antiemetic.
50307 C01 REV 010090
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
www.missionpharmacal.com
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.
Description
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 |
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.
Warning
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.
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.
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 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.
Principal Display Panel
Rx Only
NDC 0178-0866-30
The gentle option for
additional B6
CitraNatal®B-Calm
Rx Prenatal Vitamin with 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.®
CONTAINS
Six 5-day Blister Packs
Mission®
PHARMACAL
* Please review the disclaimer below.