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

PRENATAL PLUS

AvKARE, Inc.

  • 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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U.

Vitamin C (Ascorbic acid)……………………………………...........….120 mg

Vitamin D-3 (Cholecalciferol)……………….....................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mg

Thiamine (Vitamin B-1 from Thiamine Mononitrate………............…1.84 mg

Riboflavin (Vitamin B-2)………………………………………...............…3 mg

Niacin(Niacinamide)……………………………………………………....  20 mg

Vitamin B-6 (Pyridoxine HCl)…………………………………................10 mg

Folic Acid……………………………………………………............……...1 mg

Vitamin B-12 (Cyanocobalamin)……………………………................12 mcg

Calcium (Calcium Carbonate)……………………………….........…....200 mg

Iron (Ferrous Fumarate)………………………………………...........…...27 mg

Zinc (Zinc Oxide)………………………………………………...........…..25 mg

Copper (Cupric Oxide)…………………………………………...........… ..2 mg

Other ingredients: Ascorbyl Palmitate, Butylated Hydroxytoluene, Croscarmellose sodium, Dicalcium phosphate Dihydrate, DL-alpha-tocopherol, FD&C Blue # 2 lake, FD&C Red # 40, FD&C Red # 40 lake, FD&C yellow # 5, FD&C yellow # 6, FD&C yellow # 6 lake, Gelatin, Hypromellose, Magnesium stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized corn starch, Propylene Glycol, Silica, Sodium Ascorbate, Sodium Benzoate, Sorbic Acid, Starch, Stearic Acid, Sucrose, SUnflower Oil, Titanium dioxide, Triacetin, Triglycerides.

Indication

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

Dosage

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

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 progresses.

STORE AT CONTROLLED ROOM TEMPERATURE 150 - 300C (590 - 860F). AVOID EXCESS HEAT.


Vitamin and Mineral
Tablet

Multi-Vitamin

Rx Only                      100 Tablets



KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured For: AvKARE, Inc.
Pulaski, TN 38478


NDC 42291-686-01

Prenatal Plus

Vitamin and Mineral
Tablet

Multi-Vitamin

100 Tablets        Rx Only                     



KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured For: AvKARE, Inc.
Pulaski, TN 38478

Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)

Mfg. Rev. 09/12
AV 09/12

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:42291-686(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
STARCH, CORN
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 (Tan-Yellow) 19 mm G12 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-686-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-09-11


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