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.
Description
CitraNatal B-Calm ® is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6 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 B 6 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 D 3 (Cholecalciferol) | 400 IU |
| Vitamin B 6 (Pyridoxine HCl) | 25 mg |
| Folic Acid | 1 mg |
| Each vitamin B 6 tablet 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
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 B 12 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.
Storage And Handling
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 B 6 tablets each - NDC 0178-0832-30.
Principal Display Panel - Blister Pack Carton
Rx Only
NDC 0178-0832-30
The gentle option for
additional B
6
CitraNatalB-Calm®
Rx Prenatal Vitamin and two 25 mg each Vitamin B
6 tablets
A prescription
prenatal supplement
with 1 mg of folic
acid
and a high level
of vitamin B
6 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
* Please review the disclaimer below.