Citranatal Rx
FDA Label NDC 0178-0859

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Citranatal Rx (NDC 0178-0859). 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 description, indications, contraindications, warning, precautions, adverse reactions, dosage and administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

CitraNatal® Rx is a scored white oval multivitamin/multimineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other.

Each tablet contains:
Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)125 mg
Iron (Carbonyl iron, ferrous gluconate)27 mg
Vitamin D3 (Cholecalciferol)400 IU
Vitamin E (dl-alpha tocopheryl acetate)30 IU
Thiamin (Vitamin B1)3 mg
Riboflavin (Vitamin B2)3.4 mg
Niacinamide (Vitamin B3)20 mg
Vitamin B6 (Pyridoxine)20 mg
Folic Acid1 mg
Iodine (Potassium iodide)150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide)2 mg
Docusate Sodium50 mg

Indications

CitraNatal® Rx is a multivitamin/multimineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Contraindications

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

Warning

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

NOTICE: Contact with moisture can produce surface discoloration or erosion of the tablet.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage And Administration

One tablet daily or as directed by a physician. DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room temperature.

L085990

C02 Rev 005080


MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

Package Label.Principal Display Panel

CitraNatal® Rx Label
NDC: 0178-0859-90

Cnrx-0508-label-ndc-0178-0859-90-c02-l085990-90cnt-cln (Cnrx 0508 Label Ndc 0178 0859 90 C02 L085990 90cnt Cln)

Cnrx-0508-label-ndc-0178-0859-90-c02-l085990-90cnt-cln (Cnrx 0508 Label Ndc 0178 0859 90 C02 L085990 90cnt Cln)

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