Dosage Form: tablet, film coated
Complete-RF Prenatal
Prenatal Multivitamin & Multimineral Tablets
Rx Only
Complete-RF Prenatal Description
Complete-RF Prenatal Tablets are oval, dye free, white, film-coated, oil and water soluble multivitamin/multimineral tablets debossed "T008" on one side.
| Each tablet for oral administration contains: | |
| Vitamin C (ascorbic acid) | 120 mg |
| Vitamin D3 (cholecalciferol) | 400 IU |
| Vitamin E (dl-alpha tocopheryl acetate) | 30 IU |
| Vitamin B1 (thiamine mononitrate) | 3 mg |
| Vitamin B2 (riboflavin) | 3.4 mg |
| Niacin (niacinamide) | 20 mg |
| Vitamin B6 (pyridoxine hydrochloride) | 20 mg |
| Folic Acid | 1 mg |
| Vitamin B12 (cyanocobalamin) | 12 mcg |
| Calcium (calcium carbonate) | 200 mg |
| Elemental Iron (carbonyl iron) | 90 mg |
| Magnesium (magnesium oxide) | 30 mg |
| Zinc (zinc oxide) | 25 mg |
| Copper (cupric oxide) | 2 mg |
| Docusate Sodium | 50 mg |
Inactive Ingredients
Citric Acid, Croscarmellose Sodium, Fumed Silica, Gum Arabic, Magnesium Stearate, Microcrystalline Cellulose, PVP K30, Stearic Acid, TriPotassium Citrate.
Indications and Usage for Complete-RF Prenatal
Complete-RF Prenatal is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Complete-RF Prenatal can also be beneficial in improving the nutritional status of women prior to conception.
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. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
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.
Precautions
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.
Adverse Reactions
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Complete-RF Prenatal Dosage and Administration
One tablet daily or as prescribed by a physician.
How is Complete-RF Prenatal Supplied
Complete-RF Prenatal is supplied in bottles of 90 tablets.
NDC 13811-008-90
STORAGE
Store at Controlled Room Temperature 25°C (77°F); excursions permitted to 15°-30° C (59°- 86°F). [See USP]. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com
MADE IN CANADA
Rev. 11/10
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
Rx Only
NDC 13811-008-90
90 Tablets
Complete-RF
Prenatal
Prenatal Multivitamin/Multimineral Tablets
TRIGEN
LABORATORIES
| Complete-RF Prenatal ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, and docusate sodium tablet, film coated | |||||||||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 12/01/2010 | ||
| Labeler - TRIGEN Laboratories, Inc. (830479668) |
More Complete-RF Prenatal resources
- Complete-RF Prenatal Use in Pregnancy & Breastfeeding
- Drug Images
- Complete-RF Prenatal Drug Interactions
- Complete-RF Prenatal Support Group
- 21 Reviews for Complete-RF Prenatal - Add your own review/rating
Compare Complete-RF Prenatal with other medications
- Vitamin/Mineral Supplementation during Pregnancy/Lactation
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