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Focalgin B

Generic Name: pyridoxine hydrochloride, folic acid, calcium, and ginger
Dosage Form: tablet, film coated

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.

Rx only

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.

INDICATIONS

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.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions

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.

Adverse Reactions

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.

Dist. by:
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

NDC 58657-105-60
FOCALGIN-B
TABLETS
Rx ONLY
60 TABLETS

Focalgin B 
pyridoxine hydrochloride, folic acid, calcium, and ginger tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58657-105
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 42 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.22 mg
CALCIUM (CALCIUM) CALCIUM 124.23 mg
GINGER (GINGER) GINGER 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
STARCH, CORN  
HYPROMELLOSES  
TITANIUM DIOXIDE  
POLYDEXTROSE  
TALC  
MALTODEXTRIN  
MEDIUM-CHAIN TRIGLYCERIDES  
FERRIC OXIDE RED  
Product Characteristics
Color PINK Score no score
Shape OVAL (caplet) Size 16mm
Flavor Imprint Code M;105
Contains         
Packaging
# Item Code Package Description
1 NDC:58657-105-60 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/01/2013
Labeler - Method Pharmaceuticals, LLC (060216698)
Revised: 10/2013
 
Method Pharmaceuticals, LLC

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