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Prenatal Plus

Generic Name: prenatal vitamins and minerals
Dosage Form: tablet

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.

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.

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

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
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 (.beta.-carotene) .beta.-carotene 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 Ion) Thiamine 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (Niacinamide) NIACINAMIDE 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 (Ferrous Cation) Ferrous Cation 27 mg
ZINC OXIDE (Zinc Oxide) ZINC OXIDE 25 mg
CUPRIC OXIDE (Cupric Cation) 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  
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
1 NDC:42291-686-01 100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/11/2012
Labeler - AvKARE, Inc. (796560394)
Revised: 06/2014
 
AvKARE, Inc.



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