Tuesday, October 18, 2016

Centratex



vitamins and minerals

Dosage Form: capsule
Centratex

Capsules

Capsules


Iron 106 mg, Sodium Ascorbate 200 mg, Thiamine 10 mg, Riboflavin 6 mg, Pyridoxine 5mg, Folic Acid 1 mg, Cyanocobalamin 15 mcg, Niacinamide 30 mg, Pantothenic Acid 10 mg, Zinc 18.2 mg, Magnesium 6.9 mg






Copper (Copper sulfate)0.8 mg
Manganese (Manganese Sulfate)1.3 mg

A medical food, for use only under the direction and supervision of a licensed physician.



RX only



Centratex Description



Active Ingredients (Each capsule)




























Ferrous Fumerate106 mg(Iron)
Vitamin C (Sodium Ascorbate)200 mg
Vitamin B1 (Thiamine Mononitrate)10 mg
Vitamin B2 (Riboflavin)6 mg
Vitamin B6 (Pyridoxine HCL)5 mg
Folic Acid1 mg
Vitamin B1215 mcg
Niacinamide30 mg
Pantothenic Acid10 mg
Zinc (Zinc Sulfate)18.2 mg
Magnesium (Magnesium Sulfate)6.9 mg
Copper (Copper Sulfate)0.8 mg
Manganese (Manganese Sulfate)1.3 mg

Inactive Ingredients


Microcrystalline Cellulose, Silica, Magnesium Stearate, Gelatin Capsule



INDICATIONS


For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.



Contraindications


Centratex is contraindicated in patients with a known hypersensitivity to any of its ingredients. Iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, and hemolytic anemias. Folic acid may obscure signs and symptoms of pernicious anemia and is therefore a contraindication as well.



Warning


Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Iron is toxic and has been shown to cause severe reactions in children including death.



Warning


Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.



Precautions



General


Folic acid in doses above 0.1 mg – 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.



PEDIATRIC USE


Safety and effectiveness in pediatric patients has not been established.



GERIATRIC USE


No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly persons may have decreased hepatic, renal, or cardiac function.



ADVERSE REACTION


Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving Centratex shortly after meals.



Centratex Dosage and Administration


Adults only: 1 capsule daily between meals, orally. Not recommended in children.



How is Centratex Supplied


Centratex is supplied as a natural gelatin capsule with tan speckled powder. Centratex is available in bottles of 100 (NDC 23359-100-10) and bottles of 30 (NDC 23359-100-30) Dispense in a tight, light resistant container as defined in the USP/NF with a child resistant closure. Store at room temperature between 15-30 degrees C (59-86 degrees F) Keep in a cool, dry place.



RX ONLY


Centurion Labs, LLC

Birmingham, AL 35243



PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label


NDC 23359-100-10


Centratex




























Iron (Ferrous Fumarate, anhydrous)106 mg
Vitamin C (Sodium Ascorbate)200 mg
Vitamin B1 (Thiamine Mononitrate)10 mg
Vitamin B2 (Riboflavin)6 mg
Vitamin B6 (Pyridoxine HCl)5 mg
Vitamin B12 (Cyanocobalamin Concentrate)15 mcg
Folic Acid1 mg
Niacinamide (Nicotinamide)30 mg
Pantothenic Acid (Calcium Pantothenate)10 mg
Zinc (Zinc Sulfate)18.2 mg
Magnesium (Magnesium Sulfate)6.9 mg
Manganese (Manganese Sulfate)1.3 mg
Copper (Copper Sulfate)0.8 mg

CENTURION LABS

Rx Only


Net Contents: 100 capsules










Centratex 
iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, niacinamide, calcium pantothenate, zinc sulfate, magnesium sulfate, manganese sulfate, and cupric sulfate anhydrous  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)23359-100
Route of AdministrationORALDEA Schedule    












































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Iron (Iron)Iron106 mg
Sodium Ascorbate (Sodium Cation)Sodium Ascorbate200 mg
Thiamine Mononitrate (Thiamine)Thiamine Mononitrate10 mg
Riboflavin (Riboflavin)Riboflavin6 mg
Pyridoxine Hydrochloride (Pyridoxine)Pyridoxine Hydrochloride5 mg
Folic Acid (Folic Acid)Folic Acid1 mg
Cyanocobalamin (Cyanocobalamin)Cyanocobalamin15 ug
Niacinamide (Niacinamide)Niacinamide30 mg
Calcium Pantothenate (Pantothenic Acid)Calcium Pantothenate10 mg
Zinc Sulfate (zinc)Zinc Sulfate18.2 mg
Magnesium Sulfate (Magnesium)Magnesium Sulfate6.9 mg
Manganese Sulfate (Manganese)Manganese Sulfate1.3 mg
Cupric Sulfate Anhydrous (Copper)Cupric Sulfate Anhydrous0.8 mg












Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Silicon Dioxide 
Magnesium Stearate 
Gelatin 


















Product Characteristics
ColorBROWN (clear with tan speckled powder)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
123359-100-10100 TABLET In 1 BOTTLENone
223359-100-3030 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/14/2009


Labeler - Centurion Labs (806756461)
Revised: 01/2010Centurion Labs




More Centratex resources


  • Centratex Side Effects (in more detail)
  • Centratex Dosage
  • Centratex Use in Pregnancy & Breastfeeding
  • Centratex Drug Interactions
  • Centratex Support Group
  • 0 Reviews for Centratex - Add your own review/rating


  • Centratex MedFacts Consumer Leaflet (Wolters Kluwer)

  • Advanced AM/PM MedFacts Consumer Leaflet (Wolters Kluwer)

  • AquADEKs Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • B & O Monograph (AHFS DI)

  • BACiiM Monograph (AHFS DI)

  • BAL in Oil Monograph (AHFS DI)

  • Baciguent topical Monograph (AHFS DI)

  • Bacitracin Zinc eent Monograph (AHFS DI)

  • Baclofen Monograph (AHFS DI)

  • Bactocill Monograph (AHFS DI)

  • Balsalazide Disodium Monograph (AHFS DI)

  • Banzel Monograph (AHFS DI)

  • Baraclude Monograph (AHFS DI)

  • Basiliximab Monograph (AHFS DI)

  • Beclomethasone Dipropionate Monograph (AHFS DI)

  • Beconase AQ eent Monograph (AHFS DI)

  • Belladonna Monograph (AHFS DI)

  • Benazepril Hydrochloride Monograph (AHFS DI)

  • BeneFIX Monograph (AHFS DI)

  • Bentyl Monograph (AHFS DI)

  • Benzedrex Monograph (AHFS DI)

  • Benzocaine eent Monograph (AHFS DI)

  • Benzonatate Monograph (AHFS DI)

  • Benztropine Mesylate Monograph (AHFS DI)

  • Bepotastine Besilate Monograph (AHFS DI)

  • Beractant Monograph (AHFS DI)

  • Besifloxacin Hydrochloride Monograph (AHFS DI)

  • Beta Carotene Monograph (AHFS DI)

  • Betagan Monograph (AHFS DI)

  • Betamethasone Monograph (AHFS DI)

  • Betamethasone Dipropionate topical Monograph (AHFS DI)

  • Betaxolol Hydrochloride Monograph (AHFS DI)

  • Bethanechol Chloride Monograph (AHFS DI)

  • Betoptic S eent Monograph (AHFS DI)

  • Bevacizumab Monograph (AHFS DI)

  • Bexarotene Monograph (AHFS DI)

  • Bexxar Monograph (AHFS DI)

  • Bicalutamide Monograph (AHFS DI)

  • Biltricide Monograph (AHFS DI)

  • Bimatoprost Monograph (AHFS DI)

  • Biperiden Hydrochloride Monograph (AHFS DI)

  • Bisacodyl Monograph (AHFS DI)

  • Bismuth Salts Monograph (AHFS DI)

  • Bisoprolol Fumarate Monograph (AHFS DI)

  • Bivalirudin Monograph (AHFS DI)

  • Blenoxane Monograph (AHFS DI)

  • Bleph 10 Monograph (AHFS DI)

  • Boniva Monograph (AHFS DI)

  • Bontril Monograph (AHFS DI)

  • Bortezomib Monograph (AHFS DI)

  • Bosentan Monograph (AHFS DI)

  • Botox Monograph (AHFS DI)

  • Botulinum Toxin Type B Monograph (AHFS DI)

  • Brevibloc Monograph (AHFS DI)

  • Brimonidine Tartrate Monograph (AHFS DI)

  • Brinzolamide Monograph (AHFS DI)

  • Bromfenac Sodium Monograph (AHFS DI)

  • Bromocriptine Mesylate Monograph (AHFS DI)

  • Brompheniramine Maleate, Dexbrompheniramine Maleate Monograph (AHFS DI)

  • Brovana Monograph (AHFS DI)

  • Budesonide Monograph (AHFS DI)

  • Bulk-Forming Laxatives Monograph (AHFS DI)

  • Bumetanide Monograph (AHFS DI)

  • Bupivacaine Hydrochloride Monograph (AHFS DI)

  • Buprenorphine Hydrochloride Monograph (AHFS DI)

  • Bupropion Hydrochloride Monograph (AHFS DI)

  • Buspirone Hydrochloride Monograph (AHFS DI)

  • Busulfan Monograph (AHFS DI)

  • Butenafine Hydrochloride Monograph (AHFS DI)

  • Butoconazole Monograph (AHFS DI)

  • Butorphanol Tartrate Monograph (AHFS DI)

  • Byetta Monograph (AHFS DI)

  • Bystolic Monograph (AHFS DI)

  • CalciFolic-D Chewable Wafers MedFacts Consumer Leaflet (Wolters Kluwer)

  • Centrum MedFacts Consumer Leaflet (Wolters Kluwer)

  • Corvite 150 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dacarbazine Monograph (AHFS DI)

  • Daclizumab Monograph (AHFS DI)

  • Dacogen Monograph (AHFS DI)

  • Dactinomycin Monograph (AHFS DI)

  • Dalfampridine Monograph (AHFS DI)

  • Dalmane Monograph (AHFS DI)

  • Dalteparin Sodium Monograph (AHFS DI)

  • Danazol Monograph (AHFS DI)

  • Dantrium Monograph (AHFS DI)

  • Dapsone Monograph (AHFS DI)

  • Daptomycin Monograph (AHFS DI)

  • Daraprim Monograph (AHFS DI)

  • Darbepoetin Alfa Monograph (AHFS DI)

  • Darifenacin Hydrobromide Monograph (AHFS DI)

  • Darunavir Monograph (AHFS DI)

  • Dasatinib Monograph (AHFS DI)

  • Decavac Monograph (AHFS DI)

  • Declomycin Monograph (AHFS DI)

  • Deferasirox Monograph (AHFS DI)

  • Deferoxamine Mesylate Monograph (AHFS DI)

  • Delavirdine Mesylate Monograph (AHFS DI)

  • Demadex Monograph (AHFS DI)

  • Demerol Monograph (AHFS DI)

  • Denavir Monograph (AHFS DI)

  • Denileukin Diftitox Monograph (AHFS DI)

  • Denosumab Monograph (AHFS DI)

  • DepoCyt Monograph (AHFS DI)

  • Dermatop Monograph (AHFS DI)

  • Desipramine Hydrochloride Monograph (AHFS DI)

  • Desirudin Monograph (AHFS DI)

  • Desloratadine Monograph (AHFS DI)

  • Desmopressin Acetate Monograph (AHFS DI)

  • Desonide Monograph (AHFS DI)

  • Desoximetasone Monograph (AHFS DI)

  • Desoxyn Monograph (AHFS DI)

  • Desvenlafaxine Succinate Monograph (AHFS DI)

  • Detrol Monograph (AHFS DI)

  • Dexamethasone Monograph (AHFS DI)

  • Dexamethasone Sodium Phosphate eent Monograph (AHFS DI)

  • Dexlansoprazole Monograph (AHFS DI)

  • Dexmedetomidine Hydrochloride Monograph (AHFS DI)

  • Dexmethylphenidate Hydrochloride Monograph (AHFS DI)

  • Dexrazoxane Hydrochloride Monograph (AHFS DI)

  • Dextran 40 Monograph (AHFS DI)

  • Dextran 70 Monograph (AHFS DI)

  • Dextroamphetamine Monograph (AHFS DI)

  • Dextromethorphan Hydrobromide Monograph (AHFS DI)

  • Dextrose Monograph (AHFS DI)

  • Dey-Pak Monograph (AHFS DI)

  • Diabinese Monograph (AHFS DI)

  • Dialyvite 3000 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diamox Monograph (AHFS DI)

  • Diatx Zn MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diazepam Monograph (AHFS DI)

  • Diazoxide Monograph (AHFS DI)

  • Dibenzyline Monograph (AHFS DI)

  • Dibucaine Monograph (AHFS DI)

  • Dicloxacillin Sodium Monograph (AHFS DI)

  • Didanosine Monograph (AHFS DI)

  • Didronel Monograph (AHFS DI)

  • Diethylpropion Hydrochloride Monograph (AHFS DI)

  • Differin Monograph (AHFS DI)

  • Diflorasone Diacetate Monograph (AHFS DI)

  • Diflucan Monograph (AHFS DI)

  • Diflunisal Monograph (AHFS DI)

  • Difluprednate Monograph (AHFS DI)

  • Digoxin Monograph (AHFS DI)

  • Dihydroergotamine Mesylate Monograph (AHFS DI)

  • Diltiazem Hydrochloride Monograph (AHFS DI)

  • Dimenhydrinate Monograph (AHFS DI)

  • Dinoprostone Monograph (AHFS DI)

  • Dipentum Monograph (AHFS DI)

  • Diphenhydramine Hydrochloride Monograph (AHFS DI)

  • Diphenoxylate Hydrochloride Monograph (AHFS DI)

  • Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Tetanus Toxoid and Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Monograph (AHFS DI)

  • Dipivefrin Hydrochloride Monograph (AHFS DI)

  • Diprivan Monograph (AHFS DI)

  • Dipyridamole Monograph (AHFS DI)

  • Disopyramide Phosphate Monograph (AHFS DI)

  • Disulfiram Monograph (AHFS DI)

  • Diuril Monograph (AHFS DI)

  • Divalproex Sodium Monograph (AHFS DI)

  • Dobutamine Hydrochloride Monograph (AHFS DI)

  • Docetaxel Monograph (AHFS DI)

  • Docosanol Monograph (AHFS DI)

  • Docusate Salts Monograph (AHFS DI)

  • Dofetilide Monograph (AHFS DI)

  • Dolasetron Mesylate Monograph (AHFS DI)

  • Dolomite Natural MedFacts for Professionals (Wolters Kluwer)

  • Dolomite Natural MedFacts for Consumers (Wolters Kluwer)

  • Donepezil Hydrochloride Monograph (AHFS DI)

  • Dopamine Hydrochloride Monograph (AHFS DI)

  • Dopram Monograph (AHFS DI)

  • Doribax Monograph (AHFS DI)

  • Dornase Alfa Monograph (AHFS DI)

  • Dorzolamide Hydrochloride Monograph (AHFS DI)

  • Dostinex Monograph (AHFS DI)

  • Dovonex Monograph (AHFS DI)

  • Doxazosin Mesylate Monograph (AHFS DI)

  • Doxepin Hydrochloride Monograph (AHFS DI)

  • Doxercalciferol Monograph (AHFS DI)

  • Doxorubicin Hydrochloride Monograph (AHFS DI)

  • Doxycycline Monograph (AHFS DI)

  • Doxycycline Calcium Monograph (AHFS DI)

  • Doxylamine Succinate Monograph (AHFS DI)

  • Drisdol Monograph (AHFS DI)

  • Dronabinol Monograph (AHFS DI)

  • Dronedarone Hydrochloride Monograph (AHFS DI)

  • Droperidol Monograph (AHFS DI)

  • Drotrecogin Alfa (Activated) Monograph (AHFS DI)

  • Duloxetine Monograph (AHFS DI)

  • Duricef Monograph (AHFS DI)

  • Dutasteride Monograph (AHFS DI)

  • Dyclonine Hydrochloride Monograph (AHFS DI)

  • Dyrenium Monograph (AHFS DI)

  • Eldertonic

  • Ferrocite Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folgard OS MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folpace Rx MedFacts Consumer Leaflet (Wolters Kluwer)

  • Glutofac-MX MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hemocyte Plus Concise Consumer Information (Cerner Multum)

  • NIC 750 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Renatabs with Iron MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vicon Forte MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vitafol MedFacts Consumer Leaflet (Wolters Kluwer)

  • daunorubicin citrate Monograph (AHFS DI)

  • diclofenac epolamine Monograph (AHFS DI)



Compare Centratex with other medications


  • Vitamin/Mineral Supplementation and Deficiency

Posted by at
Labels:

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)