Monday, 27 February 2012

FaBB Tablets





Dosage Form: tablet
FaBB Tablets

FaBB Tablets Description


Foltabs™ Prenatal is a scored white oval multivitamin/


multimineral tablet. The tablet is debossed with “ML 160” on the scored side


and plain on the other.


Each tablet contains:


Vitamin B6 (Pyridoxine HCl) ................................................................ 25 mg


Folic Acid ................................................................................................. 2.2 mg


Cyanocobalamin ........................................................................................1 mg


INACTIVE INGREDIENTS: Dicalcium Phosphate Dihydrate, Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate



Indications and Usage for FaBB Tablets


Foltabs™ Prenatal is a multivitamin prescription supplement indicated for the use in improving the nutritional status of patients as prescribed by their physician.



Contraindications


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



Warnings


Folic acid alone is improper therapy in the treatment of pernicious anemia and other


megaloblastic anemias where vitamin B12 is deficient.


KEEP OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.



Precautions



General


NOTICE: Contact with moisture can produce surface discoloration or erosion of


the tablet.


Folic acid in doses above 0.1 mg may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.



Adverse Reactions


Allergic sensitization has been reported following both oral and parenteral administration of folic acid.



FaBB Tablets Dosage and Administration


One tablet daily or as directed by a physician.



How is FaBB Tablets Supplied


FOLCAPS Tablet is a round, pink-coated tablet debossed 'ML' on one side and '326' on the other side.


Bottles of 100 tablets ................................. NDC 68308-326-10


DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE


USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room


temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C


(59°-86°F). [See current USP].


Manufactured for:


Midlothian Laboratories


Montgomery, AL 36117


www.midlothianlabs.com


Rev. 12/09



CONTAINER LABEL


Immediate Container Label










FaBB Tablets 
vitamins tablets  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68308-326
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID2.2 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN1 mg






Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE238 mg


















Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeML;326
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
168308-326-10100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2009


Labeler - Midlothian Laboratories (142122824)
Revised: 11/2009Midlothian Laboratories

More FaBB Tablets resources


  • FaBB Tablets Use in Pregnancy & Breastfeeding
  • FaBB Tablets Drug Interactions
  • FaBB Tablets Support Group
  • 4 Reviews for FaBBs - Add your own review/rating


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