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PreNatal Vitamins Plus Package Insert

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
4000 IU, 400 IU, 25 mg, 1.84 mg, 120 mg, 12 mcg, 200 mg, 2 mg, 1 mg, 27 mg, 3 mg, 20 mg, 22 mg, 10 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - PreNatal Vitamins Plus

PreNatal Vitamins Plus

Rx Only

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Each Tablet Contains:Amount per Tablet% Daily Value
Vitamin A (Acetate and Beta Carotene)4000 I.U.80%
Vitamin C (Ascorbic Acid)120mg.200%
Vitamin D-3 (Cholecalciferol)400 I.U.100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg.73%
Vitamin B-1 (Thiamine Mononitrate)1.84 mg.123%
Vitamin B-2 (Riboflavin)3 mg.176%
Niacin (Niacinamide)20 mg100%
Vitamin B-6 (Pyridoxine HCl)10 mg.500%
Folic Acid1 mg.200%
Vitamin B-12 (Cyanocobalamin)12 mcg.200%
Calcium (from Calcium Carbonate)200 mg.20%
Iron (Ferrous Fumarate)27 mg.150%
Zinc (Zinc Oxide)25 mg.167%
Copper (Cupric Oxide)2 mg.100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono- and di-glycerides, Polyethylene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

Indications: To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of reach of children. In case of accidental overdose, call a physician or Poison Control Center immediately.

Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for: Boca Pharmacal, Inc., Coral Springs, FL 33065

www.bocapharmacal.com 1-800-354-8460 Iss. 06/12

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: June 2012

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Drug information for PreNatal Vitamins Plus

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Calcium, Copper-containing Intrauterine Device, Nicotinic Acid, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A 4000 IU, Cholecalciferol 400 IU, Zinc 25 mg, Thiamine 1.84 mg, Ascorbic acid 120 mg, Cyanocobalamin 12 mcg, Calcium 200 mg, Copper 2 mg, Folic acid 1 mg, Iron 27 mg, Riboflavin 3 mg, Niacin 20 mg, Alpha-tocopherol acetate 22 mg, Pyridoxine 10 mg
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Bryant Ranch Prepack
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Packages (NDC)
Package
4000 IU, 400 IU, 25 mg, 1.84 mg, 120 mg, 12 mcg, 200 mg, 2 mg, 1 mg, 27 mg, 3 mg, 20 mg, 22 mg, 10 mg – 100 in 1 bottle NDC 63629-3545-1
4000 IU, 400 IU, 25 mg, 1.84 mg, 120 mg, 12 mcg, 200 mg, 2 mg, 1 mg, 27 mg, 3 mg, 20 mg, 22 mg, 10 mg – 30 in 1 bottle NDC 63629-3545-2
4000 IU, 400 IU, 25 mg, 1.84 mg, 120 mg, 12 mcg, 200 mg, 2 mg, 1 mg, 27 mg, 3 mg, 20 mg, 22 mg, 10 mg – 90 in 1 bottle NDC 63629-3545-3

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.