Prenatal Plus

multivitamin, multimineral supplement

Dosage Form: tablet, film coated

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.

Prenatal Plus Vitamin and Mineral Tablet

NDC 65162-668-10: Plastic bottle containing 100 Tablets

NDC 65162-668-50: Plastic bottle containing 500 Tablets

Dispense in a well closed light-resistant container, with a child resistant container.

NDC 65162-668-10


Prenatal Plus

Vitamin and Mineral

Tablet


Multi-Vitamin


Rx Only                      100 Tablets

amneal Pharmaceuticals

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


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

Manufactured By: Gemini Pharmaceuticals, Commack, NY 11725

Distributed By: Amneal Pharmaceuticals, 104 Hippocrates Way, Glasgow, KY 42141

Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)

NDC 65162-668-50


Prenatal Plus

Vitamin and Mineral

Tablet


Multi-Vitamin


Rx Only                      500 Tablets

amneal Pharmaceuticals

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


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

Manufactured By: Gemini Pharmaceuticals, Commack, NY 11725

Distributed By: Amneal Pharmaceuticals, 104 Hippocrates Way, Glasgow, KY 42141

Prenatal Plus Vitamin and Mineral Tablet (500 Tablets)

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 NDC Product Code (Source) 65162-668 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (VITAMIN A) VITAMIN A 3080 [iU] BETA CAROTENE (VITAMIN A) VITAMIN A 920 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL, DL-) ALPHA-TOCOPHEROL, DL- 22 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE 1.84 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg NIACINAMIDE (NIACIN) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 10 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg FERROUS FUMARATE (IRON) IRON 27 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (COPPER) COPPER 2 mg

Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE   BUTYLATED HYDROXYTOLUENE   CROSCARMELLOSE SODIUM   DIBASIC CALCIUM PHOSPHATE DIHYDRATE   ALPHA-TOCOPHEROL, DL-   FD&C RED NO. 40   FD&C YELLOW NO. 5   FD&C YELLOW NO. 6   GELATIN   HYPROMELLOSE   MAGNESIUM STEARATE   MALTODEXTRIN   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   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 yellow (Tan-Yellow) Score no score Shape OVAL (Modified Oval Biconvex) Size 19mm Flavor Imprint Code G12 Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-668-10 100 TABLET In 1 BOTTLE, PLASTIC None 2 65162-668-50 500 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		12/02/2009

Labeler - AMNEAL PHARMACEUTICALS, LLC (804220023)

Registrant - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture

Revised: 12/2009AMNEAL PHARMACEUTICALS, LLC

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