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Prenatal Plus Iron Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
3080 IU, 920 IU, 120 mg, 400 IU, 22 IU, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 29 mg, 25 mg, 2 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Prenatal Plus Iron

DESCRIPTION

Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, 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 I.U.

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 (Carbonyl Iron)..............................................................................29 mg

Zinc (Zinc Oxide).................................................................................25 mg

Copper (Cupric Oxide)..........................................................................2 mg

Other ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow # 5 lake, FD&C Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene 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 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

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 progesses.

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 Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE

Store at room temperature. Dispense in a well closed light resistant container with a child resistant cap.

HOW SUPPLIED

NDC 0904-5339-60 plastic bottle containing 100 Tablets.

About this document

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

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Prenatal Plus Iron

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 Blood Coagulation Factor, Phosphate Binder, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A acetate 3080 IU, Beta-carotene 920 IU, Ascorbic acid 120 mg, Cholecalciferol 400 IU, Alpha-tocopherol acetate, DL- 22 IU, Thiamine mononitrate 1.84 mg, Riboflavin 3 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 10 mg, Folic acid 1 mg, Cyanocobalamin 12 mcg, Calcium carbonate 200 mg, Iron pentacarbonyl 29 mg, Zinc oxide 25 mg, Cupric oxide 2 mg
Dosage form Tablet, film coated
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Blenheim Pharmacal, Inc.
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Packages (NDC)
Package
3080 IU, 920 IU, 120 mg, 400 IU, 22 IU, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 29 mg, 25 mg, 2 mg – 31 in 1 bottle, plastic NDC 10544-609-31

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.