Matronex

Matronex
SPL v1
SPL
SPL Set ID c47457a4-0774-4286-b91f-88aea2f1dc01
Route
ORAL
Published
Effective Date 2025-10-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Vitamin A (1500 ug) Riboflavin (3 mg) Niacinamide (3.4 mg) Pyridoxine (20 mg) Cyanocobalamin (50 mg) Ascorbic Acid (10 ug) Cholecalciferol (120 mg) .alpha.-tocopherol, Dl- (20 ug) Folic Acid (30 mg) Calcium Cation (1000 ug) Choline (200 mg) Chromic Cation (55 mg) Ferrous Cation (45 ug) Iodide Ion (27 mg) Magnesium Cation (150 ug) Manganous Cation (2.6 mg) Molybdenum (50 ug) Selenium (70 ug) Zinc Cation (25 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-09-11

Description

Matronex Prenatal Tablets Dispensed by Prescription


Medication Information

Description

Matronex Prenatal Tablets Dispensed by Prescription

Label:

Dosage:

Adults (persons over 12 years of age) One (1) Matronex caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Warnings: 

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

Matronex Prenatal Vitamins should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Description:

Matronex Prenatal Tablets are brown, round tablets dispensed in plastic bottles of 30 ct.

85622-0200-30

Reserved for Professional Recommendation

Matronex Prenatal Tablets are an orally administered prescription vitamin to provide significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, thiamine monoitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamines will not develop.

Matronex Prenatal Tablets should be administered under the supervision of a licensed medical practitioner.

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

Blue Heron Pharmaceuticals

Lutz, FL 33559

Indications:

Matronex is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.



Matronex may be beneficial in improving the nutritional status of women prior to conception.

Precautions:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Pretrate should be stored beyond the reach of children to prevent against accidental iron poisoning. 

CONTRAINDICATIONS

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

PRECAUTIONS

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

ADVERSE REACTIONS

Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Health Claim:

Matronex Prenatal Tablets

Dispensed by Prescription


Structured Label Content

Label:

Dosage: (DOSAGE:)

Adults (persons over 12 years of age) One (1) Matronex caplet daily, between meals, or as directed by a physician. Do not administer to children under the age of 12.

Storage: (STORAGE:)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Warnings:  (WARNINGS: )

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

Matronex Prenatal Vitamins should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Description: (DESCRIPTION:)

Matronex Prenatal Tablets are brown, round tablets dispensed in plastic bottles of 30 ct.

85622-0200-30

Reserved for Professional Recommendation

Matronex Prenatal Tablets are an orally administered prescription vitamin to provide significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, thiamine monoitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamines will not develop.

Matronex Prenatal Tablets should be administered under the supervision of a licensed medical practitioner.

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

Blue Heron Pharmaceuticals

Lutz, FL 33559

Indications: (INDICATIONS:)

Matronex is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years.



Matronex may be beneficial in improving the nutritional status of women prior to conception.

Precautions: (PRECAUTIONS:)

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Pretrate should be stored beyond the reach of children to prevent against accidental iron poisoning. 

CONTRAINDICATIONS

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

PRECAUTIONS

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

ADVERSE REACTIONS

Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Health Claim: (HEALTH CLAIM:)

Matronex Prenatal Tablets

Dispensed by Prescription


Advanced Ingredient Data


Raw Label Data

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