CitraNatal DHA

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# Black Box Warning

# Overview
CitraNatal DHA is a multi-vitamin/mineral that is FDA approved for the {{{indicationType}}} of improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.. There is a Black Box Warning for this drug as shown here.  Common adverse reactions include allergic reactions.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Dosing Information
- CitraNatal DHA 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.
- One tablet and one soft gel daily or as directed by a physician.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of CitraNatal DHA in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of CitraNatal DHA in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of CitraNatal DHA in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of CitraNatal DHA in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of CitraNatal DHA in pediatric patients.

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

# Warnings
- 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. 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.
- 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

## Clinical Trials Experience
- Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of CitraNatal DHA in the drug label.

# Drug Interactions
There is limited information regarding CitraNatal DHA Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of CitraNatal DHA in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of CitraNatal DHA during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of CitraNatal DHA with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of CitraNatal DHA with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of CitraNatal DHA with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of CitraNatal DHA with respect to specific gender populations.

### Race
There is no FDA guidance on the use of CitraNatal DHA with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of CitraNatal DHA in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of CitraNatal DHA in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of CitraNatal DHA in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of CitraNatal DHA in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of CitraNatal DHA in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of CitraNatal DHA in the drug label.

# Overdosage

## Acute Overdose

### Signs and Symptoms

### Management

## Chronic Overdose
There is limited information regarding Chronic Overdose of CitraNatal DHA in the drug label.

# Pharmacology
There is limited information regarding CitraNatal DHA Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding CitraNatal DHA Mechanism of Action in the drug label.

## Structure
- CitraNatal DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed CN 1 on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of CitraNatal DHA in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of CitraNatal DHA in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of CitraNatal DHA in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of CitraNatal DHA in the drug label.

# How Supplied
- Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.
- To report a serious adverse event or obtain product information, call (210) 696-8400.
- Please consult your health care provider with any dietary concerns.
- Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimalized.
- NOTICE: Contact with moisture can discolor or erode the tablet.

## Storage
There is limited information regarding CitraNatal DHA Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of CitraNatal DHA in the drug label.

# Precautions with Alcohol
- Alcohol-CitraNatal DHA interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- CitraNatal DHA

# Look-Alike Drug Names
There is limited information regarding CitraNatal DHA Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price