PreTAB (.beta.-carotene 4000 [iu] ascorbic acid 120 mg cholecalciferol 400 [iu] .alpha.-tocopherol acetate, dl- 30 [iu] thiamine mononitrate 3 mg riboflavin 3 mg niacinamide 20 mg pyridoxine hydrochloride 3 mg folic acid 1 mg cyanocobalamin 8 ug calcium carbonate 200 mg ferrous fumarate 29 mg potassium iodide 150 ug zinc oxide 15 mg) Dailymed
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Health Claim Section
69543-259-10
Rx
PRENATAL / POSTNATAL
Prescription Multivitamin Dietary Supplement
Description
PreTAB Tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is an orally administered prescription prenatal/postnatal dietary supplement and should be administered under the supervision of a health care provider.
Supplement Facts Serving Size: 1 Tablet Amount Per Serving % Daily Value for Pregnant and Lactating Women Vitamin A (as beta carotene) 4000 IU 50% Vitamin C (ascorbic acid) 120 mg 200% Vitamin D (Vitamin D3 as cholecalciferol) 400 IU 100% Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100% Thiamin (Vitamin B1 thiamine mononitrate) 3 mg 176% Riboflavin (Vitamin B2) 3 mg 150% Niacin (as niacinamide) 20 mg 100% Vitamin B6 (pyridoxine HCl) 3 mg 120% Folic Acid 1 mg 125% Vitamin B12 (cyanocobalamin) 8 mcg 100% Calcium (as calcium carbonate) 200 mg 15% Iron (as ferrous fumarate) 29 mg 161% Iodine (potassium iodide) 150 mcg 100% Zinc (as zinc oxide) 15 mg 100%
Other ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide , Hypromellose, Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Red #40, FD&C Yellow #6 and FD&C Blue #1.
Side Effects
Folic acid. Most adults do not experience side effects when taking oral folic acid. Allergic reactions have been reported, and mild side effects, which usually occur with relatively large doses of folic acid supplements, include nausea, insomnia, decreased appetite, flatulence, abdominal distension, difficulty concentrating and some bitter taste in the tongue. If you experience any of these, talk with your health care provider.
Thiamin (Vitamin B1) usually has no side effects. A very serious allergic reaction is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Riboflavin (Vitamin B2) usually has no side effects, but large amounts may cause urine to be more yellow than normal.
Pyridoxine (Vitamin B6) usually has no side effects, but rarely numbness and tingling, sleepiness, nausea, and headaches have been reported with pyridoxine. Allergy and hypersensitivity reactions are rare.
Cyanocobalamin (Vitamin B12) usually has no side effects. However, mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body, muscle cramps, weakness, irregular heartbeat have been seen rarely.
Ascorbic Acid (Vitamin C) has no side effects in many people, but diarrhea, nausea, vomiting, abdominal cramps or heartburn have occurred.
Patient Information
This product is a prescription prenatal multivitamin dietary supplement to be used only as prescribed by your health care provider. Your health care provider may choose to prescribe this product along with other medications. Your healthcare provider may prescribe PreTAB for other conditions.
Indications And Usage
PreTAB prescription multivitamin tablets are used for the nutritional support of pregnant and lactating women.
Warnings Section
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.
Interactions
If you are taking any prescription or over-the-counter medicines, or herbal supplements talk with your health care provider and/or pharmacist before taking them together with this product because they may interact with folate.
Contraindications
This product is contraindicated for persons with a known hypersensitivity to any of the ingredients and for persons with conditions for which any of the ingredients are contraindicated.
Warnings
Overdose can be quite dangerous to epileptics as folate has been seen to cause seizures. Allergic reactions have also been reported in a few cases.
Caution
Patients with a history of bipolar illness, as mood elevation is possible following co-administration of folate with antidepressant therapy.
Pregnancy And Nursing Mothers
PreTAB tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is intended for use as a prescription PRENATAL folate before, during, and after pregnancy.
Directions For Use
One tablet daily or as directed by a healthcare provider.
Storage
Store at Controlled Room Temperature 15°to 30°C (59°to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.
How Supplied
PreTAB tablet (PNV-Ca with 29 mg Fe; 1 mg FA) is supplied as oblong, pink tablets, Imprinted "V259", dispensed in bottles of 100 tablets.
69543-259-10
Keep This Out Of Reach Of Children.
Call your healthcare provider about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.
Rx
Manufactured for: Virtus Pharmaceuticals, LLC Tampa, Florida 33619 1-888-848-3593 MADE IN USA
Rev. 08/2016
Principal Display Panel - 100 Tablet Bottle Label
VIRTUS PHARMACEUTICALS
69543-259-10
PreTAB Tablet(PNV-Ca with 29 mg Fe; 1 mg FA)
PRENATAL / POSTNATAL
Prescription MultivitaminDietary Supplement
Rx 100 TabletsMade in USA
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