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Prenatal Plus

Generic name: prenatal vitamins and minerals
Dosage form: tablet
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 1, 2020.

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: 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

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.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORE AT CONTROLLED ROOM TEMPERATURE 15 0 - 30 0C (59 0 - 86 0F). 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.

Questions or comments call 1-855-361-3993

Manufactured For:
AvKARE, Inc.
Pulaski, TN 38478


Mfg.Rev. 09/12 AV Rev. 07/17 (P)


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 Rev. 07/17 (P)

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 (VITAMIN A) VITAMIN A 3080 [iU]
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 22 mg
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 920 [iU]
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 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
STARCH, CORN
PROPYLENE GLYCOL
SILICON DIOXIDE
SODIUM ASCORBATE
SODIUM BENZOATE
SORBIC ACID
STEARIC ACID
SUCROSE
SUNFLOWER OIL
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE GLYCOL, UNSPECIFIED
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)
AvKARE, Inc.