Generic name: pyridoxine hydrochloride, folic acid, calcium, and ginger
Dosage form: tablet, film coated
Drug class: Vitamin and mineral combinations
Medically reviewed by Drugs.com. Last updated on Sep 21, 2020.
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.
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Focalgin B Description
Focalgin-B™ Tablets are a prescription prenatal vitamin that provide B-vitamin nutrition and are formulated with vitamin B6 and ginger to help calm nausea and vomiting of pregnancy (NVP). Focalgin-B™ Tablets contain 100 mg ginger root powder extract that, when standardized to ginerols, is equivalent to 500 mg ginger root powder.
Each caplet shaped tablet is engraved “M-105” on one side with a pink film coat.
Each pink tablet contains:
Vitamin B6 (pyridoxine hydrochloride, USP) ..... 42 mg
Folic Acid, USP ..... 1.22 mg
Calcium (as dicalcium phosphate and tricalcium phosphate)..... 124.23 mg
Ginger (zingiber officinale) root powder extract .....100 mg
Other Ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, opadry pink, silicon dioxide, starch.
Folcalgin-B™ Tablets are indicated to provide B-vitamin supplementation, with ginger to help calm pregnancy related nausea and vomiting (morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Focalgin B Dosage and Administration
One or two tablets daily, in divided doses, or as directed by a physician.
How is Focalgin B Supplied
Bottles of 60 tablets (NDC 58657-105-60).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DO NOT CHEW.
Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture.
Method Pharmaceuticals, LLC
Arlington, TX 76006
1-877-250-3427 www. methodpharm.com
©2013 Method Pharmaceuticals, LLC All rights reserved. Rev. 9/2013
PRINCIPAL DISPLAY PANEL
pyridoxine hydrochloride, folic acid, calcium, and ginger tablet, film coated
|Labeler - Method Pharmaceuticals, LLC (060216698)|