CitraNatal Assure Rx Prenatal Tablet

Formulation re: Other

When you Want Complete Care Quality ingredients, true comfort: Stool softener

Formula re: Contains

35 mg Ferr-Ease dual-iron 300 mg DHA 124 mg Calcium (calcium citrate)

General Statements: All Other Content

Please see side of carton for other important ingredients. Rx Only

Precautions re: Children

Six 5-Day Blister Packs in Child-Resistant Packaging

Formula re: Contains

Description: CitraNatal Assure is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease, a dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a white coated, oval multi-vitamin/mineral tablet.

Formulation re: Other

The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA soft gel is oblong, transparent, and caramel colored.

Formula re: Type

Indications: CitraNatal Assure is a multi-vitamin/mineral 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.

Precautions re: All Other

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

Precautions re: Children

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions re: All Other

Warning: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR.

Precautions re: Pregnant or Nursing or Prescription Medications

Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions re: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Precautions: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Precautions re: Allergies

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

Precautions re: All Other

Caution: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Suggested/Recommended/Usage/Directions

Dosage and Administration: One tablet and one soft gel daily or as directed by a physician.

Storage

Storage: Store at 20 degrees C to 25 degrees C (68 degrees F to 77 degrees F), excursions permitted between 15 degrees C and 30 degrees C (between 59 degrees F and 86 degrees F). Brief exposure to temperatures up to 40 degrees C (104 degrees F) may be tolerated provided the mean kinetic temperature does not exceed 25 degrees C (77 degrees F); however, such exposure should be minimized.

Storage

Notice: Contact with moisture can discolor or erode the tablet.

General Statements: All Other Content

How Supplied: Six children-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0891-30.

Precautions re: All Other

To report a serious adverse event or obtain product information, call (800) 298-1087. Please consult your health care provider with any dietary concerns.

Formula re: Contains

Ferr-Ease Dual-iron delivery

Brand IP Statement(s) re: (c), (TM), (SM)

Ferr-Ease Dual-iron delivery Trademark of Mission Pharmacal Company Copyright 2020 Mission Pharmacal Company. All rights reserved.