PRENATAL PLUS description, usages, side effects, indications, overdosage, supplying and lots more!

PRENATAL PLUS

Amneal Pharmaceuticals, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Prenatal PlusVitamin and Mineral TabletMulti-VitaminRx Only

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), 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

PRINCIPAL DISPLAY PANEL

 PRINCIPAL DISPLAY PANEL

PRENATAL PLUS

VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65162-668
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE 3080 [iU]
.BETA.-CAROTENE .BETA.-CAROTENE 920 [iU]
ASCORBIC ACID ASCORBIC ACID 120 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 22 mg
THIAMINE MONONITRATE THIAMINE ION 1.84 mg
RIBOFLAVIN RIBOFLAVIN 3 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 10 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE 200 mg
FERROUS FUMARATE FERROUS CATION 27 mg
Zinc Oxide Zinc oxide 25 mg
CUPRIC OXIDE CUPRIC CATION 2 mg

Inactive Ingredients

Ingredient Name Strength
ASCORBYL PALMITATE
BUTYLATED HYDROXYTOLUENE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
.ALPHA.-TOCOPHEROL, DL-
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
propylene glycol
SILICON DIOXIDE
sodium ascorbate
SODIUM BENZOATE
sorbic acid
STARCH, CORN
STEARIC ACID
SUCROSE
SUNFLOWER OIL
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm G12 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65162-668-10 100 in 1 BOTTLE, PLASTIC
2 NDC:65162-668-50 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-12-02


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