FDA Label for Prenatal Plus
View Indications, Usage & Precautions
Prenatal Plus Product Label
The following document was submitted to the FDA by the labeler of this product Amneal Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Each Tablet Contains:
VITAMINS: Amount per Tablet
Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU
Vitamin C (Ascorbic Acid) ........................................................... 120 mg
Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU
Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 IU
Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg
Riboflavin (Vitamin B-2) .................................................................. 3 mg
Niacin (as Niacinamide) ................................................................ 20 mg
Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg
Folic Acid ......................................................................................... 1 mg
Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg
MINERALS: Amount per Tablet
Calcium (as Calcium Carbonate) ................................................. 200 mg
Iron (from Ferrous Fumarate) ........................................................ 27 mg
Zinc (from Zinc Oxide) ................................................................... 25 mg
Copper (from Cupric Oxide) ........................................................... 2 mg
Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide
Indications And Usage
To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
Warnings
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. |
Precautions
Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.
Dosage And Administration
As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.
How Supplied
Bottles of 100: NDC 65162-668-10
Bottles of 500: NDC 65162-668-50
Storage
STORE AT CONTROLLED ROOM TEMPERATURE 15° to 30°C (59° to 86°F), AVOID EXCESS HEAT.
Dispense in a well closed light-resistant container, with a child resistant cap.
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.
Manufactured by:
Nexgen Pharma
Colorado Springs, CO 80905
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Rev. 09-2012
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