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Name:Prenatal Plus
Manufacturer:Physicians Total Care, Inc.
Category:Prescription Marketed Drugs


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 and cupric oxide tablet, film coated 
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

DESCRIPTION

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 AND ADMINISTRATION

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

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 progresses.

HOW SUPPLIED

Prenatal Plus Vitamin and Mineral Tablet

NDC 54868-0190-0
NDC 54868-0190-1
Bottles of 30
Bottles of 100
Dispense in a well closed light-resistant container, with a child resistant container.



KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

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


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



Manufactured By: Gemini Pharmaceuticals, Commack, NY 11725
Distributed By: Amneal Pharmaceuticals, 104 Hippocrates Way, Glasgow, KY 42141


Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK     74146

PRINCIPAL DISPLAY PANEL

Prenatal Plus Vitamin and Mineral Tablet

image of package label


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 Item Code (Source) NDC:54868-0190(NDC: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  
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
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0190-0 30 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0190-1 100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/09/2009

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 08/2010 Physicians Total Care, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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