Prenatal Vitamins Plus Low Iron Tablet
FDA Label NDC 50090-0616

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Prenatal Vitamins Plus Low Iron (NDC 50090-0616). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding boxed warning, description, indications & usage, dosage & administration, contraindications, precautions, storage and handling, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Boxed Warning

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

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.

Description

Each Tablet Contains:Amount
Per Tablet		% Daily
Value
Vitamin A (from Acetate and Beta Carotene)4000 IU80%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D-3 (Cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%
Vitamin B-1(Thiamine Mononitrate)1.84 mg123%
Vitamin B-2 (Riboflavin)3 mg176%
Niacin (as Niacinamide)20 mg100%
Vitamin B-6 (Pyridoxine HCI)10 mg500%
Folic Acid1 mg200%
Vitamin B-12 (Cyanocobalamin)12 mcg200%
Calcium (from Calcium Carbonate)200 mg20%
Iron (Ferrous Fumarate)27 mg150%
Zinc (Zinc Oxide)25mg167%
Copper (Cupric Oxide)2 mg100%

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, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

Indications & Usage

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.

Dosage & Administration

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

Contraindications

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

Precautions

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

Storage And Handling

Store at room temperature, USP. Dispense in a well closed light resistant container.

How Supplied

Product: 50090-0616

NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC

NDC: 50090-0616-1 30 TABLET in a BOTTLE

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