CitraNatal Harmony

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 increase 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 diatheses.

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. Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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 soft gel daily or as directed by a physican.

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.

Formulation re: Other

Notice: Contact with moisture can discolor or erode the soft gel.

General Statements: All Other Content

N Rx only

FDA Statement of Identity

Rx Prenatal Supplement Soft Gel

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.

Formulation re: Other

Description: CitraNatal Harmony is a prescription prenatal/postnatal multi-vitamin/mineral soft gel with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron, and DHA, an essential fatty acid.

General Statements: All Other Content

The prenatal vitamin is a purple, opaque soft gel containing a greenish-gray liquid to semi-solid fill. The soft gel is printed "0796" in white ink.

Formula re: Type

Indications: CitraNatal Harmony 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 an nonlactating mothers.

Precautions re: All Other

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

General Statements: All Other Content

How Supplied: Bottles of 30 soft gels each -

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.

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

Ferr-Ease Dual iron delivery Trademark of Mission Pharmacal Company U.S Patent No. 6,521,247

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

life'sDHA CitraNatal Assure contains life'sDHA, a trademark of DSM

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

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