Ipecacuanha

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Ipecacuanha is a OTC emetic that is FDA approved for the treatment of of Poisoning, acute by inducing vomiting. Common adverse reactions include Diarrhea, Stomach cramps, Myalgia and Lethargy.

• Poisoning, acute^[1][2]
• to induce NAUSEA AND VOMITING

• Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

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

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ipecacuanha in adult patients.

• Poisoning, acute^[1]

• Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

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

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ipecacuanha in pediatric patients.

There is limited information regarding Ipecacuanha Contraindications in the drug label.

There is limited information regarding Ipecacuanha Warnings’ in the drug label.

• Diarrhea^[3]
• Stomach cramps
• Myalgia
• Lethargy^[3]

There is limited information regarding Ipecacuanha Postmarketing Experience in the drug label.

There is limited information regarding Ipecacuanha Drug Interactions in the drug label.

Pregnancy Category (FDA):

• If pregnant or breast-feeding, ask a health professional before use

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ipecacuanha in women who are pregnant.

There is no FDA guidance on use of Ipecacuanha during labor and delivery.

• If pregnant or breast-feeding, ask a health professional before use

There is no FDA guidance on the use of Ipecacuanha with respect to pediatric patients.

There is no FDA guidance on the use of Ipecacuanha with respect to geriatric patients.

There is no FDA guidance on the use of Ipecacuanha with respect to specific gender populations.

There is no FDA guidance on the use of Ipecacuanha with respect to specific racial populations.

There is no FDA guidance on the use of Ipecacuanha in patients with renal impairment.

There is no FDA guidance on the use of Ipecacuanha in patients with hepatic impairment.

There is no FDA guidance on the use of Ipecacuanha in women of reproductive potentials and males.

There is no FDA guidance one the use of Ipecacuanha in patients who are immunocompromised.

• Oral

There is limited information regarding Monitoring of Ipecacuanha in the drug label.

There is limited information regarding IV Compatibility of Ipecacuanha in the drug label.

There is limited information regarding Overdose of Ipecacuanha in the drug label.

There is limited information regarding Ipecacuanha Pharmacology in the drug label.

There is limited information regarding Ipecacuanha Mechanism of Action in the drug label.

IPECACUANHA 3X

(Ipecac)

Lactose, sucrose.

There is limited information regarding Pharmacodynamics of Ipecacuanha in the drug label.

There is limited information regarding Pharmacokinetics of Ipecacuanha in the drug label.

There is limited information regarding Nonclinical Toxicology of Ipecacuanha in the drug label.

There is limited information regarding Clinical Studies of Ipecacuanha in the drug label.

There is limited information regarding Ipecacuanha How Supplied in the drug label.

• Store at room temperature.

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• QUESTIONS?

1-800-404-4666

• Alcohol-Ipecacuanha interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

• IPECACUANHA®^[4]

There is limited information regarding Ipecacuanha Look-Alike Drug Names in the drug label.

The contents of this FDA label are provided by the National Library of Medicine.