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Prenatal Plus Package Insert

Updated:
Facts
Status:
Prescription (Rx)
Strength:
3080 IU, 920 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 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

DESCRIPTION

Each Tablet Contains:

VITAMINS: Amount per Tablet

Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU

Vitamin C (Ascorbic Acid) ........................................................... 120 mg

Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU

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 (as Niacinamide) ................................................................ 20 mg

Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg

Folic Acid ......................................................................................... 1 mg

Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg

MINERALS: Amount per Tablet

Calcium (as Calcium Carbonate) ................................................. 200 mg

Iron (from Ferrous Fumarate) ........................................................ 27 mg

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

Copper (from 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

INDICATIONS AND USAGE

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.

WARNINGS

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.

DOSAGE AND ADMINISTRATION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

HOW SUPPLIED

Bottles of 100: NDC 65162-668-10

Bottles of 500: NDC 65162-668-50

Storage

STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.

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

KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by:

Nexgen Pharma

Colorado Springs, CO 80905

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 09-2012

About this document

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

Revision date stated in the text: September 2012

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

Drug information for Prenatal Plus

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
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 mg, 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, Ferrous fumarate 27 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) Amneal Pharmaceuticals LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
3080 IU, 920 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 mg, 25 mg, 2 mg – 100 in 1 bottle, plastic NDC 65162-668-10
3080 IU, 920 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 mg, 25 mg, 2 mg – 500 in 1 bottle, plastic NDC 65162-668-50

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.