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
- NDC Code(s): 42291-686-01
- Packager: AvKARE, Inc.
- This is a repackaged label.
- Source NDC Code(s): 65162-668
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated January 17, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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: 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
- Dosage
- BOXED WARNING (What is this?)
-
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.
- STORAGE AND HANDLING
- HOW SUPPLIED
-
PRINCIPAL DISPLAY PANEL
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 38478Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)
Mfg. Rev. 09/12
AV Rev. 07/17 (P) -
INGREDIENTS AND APPEARANCE
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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-686(NDC:65162-668) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 3080 [iU] CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.84 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 22 mg .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 920 [iU] ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 10 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBATE (UNII: S033EH8359) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBIC ACID (UNII: X045WJ989B) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) SUNFLOWER OIL (UNII: 3W1JG795YI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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 Marketing Start Date Marketing End Date 1 NDC:42291-686-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2017 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)