FDA approved Zyrtec-d 12 Hour (cetirizine/pseudoephedrine) for Allergy SymptomsFDA approved Zyrtec-d 12 Hour for allergy and sinus relief.

FDA From the archive Source published August 10, 2001 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Zyrtec-d 12 Hour for temporary relief of allergy symptoms including nasal congestion; caution with MAOIs and in patients with certain medical conditions.

The FDA has approved Zyrtec-d 12 Hour (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg) for temporary relief of symptoms due to hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy watery eyes, itching of the nose or throat, nasal congestion, sinus congestion and pressure, and to restore freer breathing through the nose. The combination product pairs the antihistamine cetirizine with the decongestant pseudoephedrine in an extended-release tablet. For clinicians, this approval offers a nonprescription option for patients requiring both antihistamine and decongestant therapy. The label notes that drowsiness may occur and advises caution when driving or operating machinery. Patients should not exceed 2 tablets in 24 hours and should avoid alcohol, sedatives, and tranquilizers.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Cetirizine is a histamine-1 (H1) receptor antagonist. Pseudoephedrine is a sympathomimetic amine that acts as a decongestant by constricting blood vessels in the nasal passages.

Indication & Patient Population

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itchy watery eyes, itching of the nose or throat, nasal congestion; reduces swelling of nasal passages; temporarily relieves sinus congestion and pressure; temporarily restores freer breathing through the nose.

Dosing & Administration

Do not break or chew tablet; swallow tablet whole. Adults and children 12 years and over: take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. Adults 65 years and over: ask a doctor. Children under 12 years of age: ask a doctor. Consumers with liver or kidney disease: ask a doctor.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug. Ask a doctor before use if you have heart disease, thyroid disease, diabetes, glaucoma, high blood pressure, trouble urinating due to an enlarged prostate gland, liver or kidney disease. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product: do not use more than directed; drowsiness may occur; avoid alcoholic drinks; alcohol, sedatives, and tranquilizers may increase drowsiness; be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if an allergic reaction occurs, you get nervous, dizzy, or sleepless, symptoms do not improve within 7 days or are accompanied by fever. If pregnant or breast-feeding: if breast-feeding, not recommended; if pregnant, ask a health professional before use.

Place in Therapy

Zyrtec-d 12 Hour is a nonprescription combination product for temporary relief of allergy symptoms including nasal congestion. It may be considered for patients who require both antihistamine and decongestant therapy. Clinicians should counsel patients on proper dosing, potential drowsiness, and contraindications including MAOI use.

The FDA has approved Zyrtec-d 12 Hour (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg) for temporary relief of symptoms due to hay fever or other upper respiratory allergies. These symptoms include runny nose, sneezing, itchy watery eyes, itching of the nose or throat, nasal congestion, sinus congestion and pressure, and to help you breathe more freely through your nose. This product is a combination of an antihistamine (cetirizine) and a decongestant (pseudoephedrine) in one extended-release tablet.

Zyrtec-d 12 Hour is available without a prescription. It is for adults and children 12 years and older. The approval means you now have a nonprescription option that treats both allergy and congestion symptoms together. However, the label warns that drowsiness may occur, so use caution when driving or operating machinery. Do not take more than 2 tablets in 24 hours. Avoid alcohol, sedatives, and tranquilizers while taking this medicine.

This approval does not mean the drug is right for everyone. If you have high blood pressure, heart disease, thyroid problems, diabetes, or trouble urinating due to an enlarged prostate, talk to your doctor before using this product. Also, if you are pregnant or breastfeeding, ask a health professional before use. Always read and follow the label carefully. For any questions about your specific health situation, talk to your doctor or pharmacist.

What this means for you:

Zyrtec-d 12 Hour is a new nonprescription combo pill for allergy and sinus relief, but check with your doctor if you have health conditions.

Study Details

Study typeFda approval

PublishedAug 2001

View Original Abstract ↓

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

FDA approved Zyrtec-d 12 Hour (cetirizine/pseudoephedrine) for Allergy SymptomsFDA approved Zyrtec-d 12 Hour for allergy and sinus relief.

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

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FDA approved Zyrtec-d 12 Hour (cetirizine/pseudoephedrine) for Allergy SymptomsFDA approved Zyrtec-d 12 Hour for allergy and sinus relief.

Study Details

Budesonide-glycopyrronium-formoterol fumarate dihydrate improved lung function and reduced severe exacerbations versus budesonide-formoterol in inadequately controlled asthma

New Asthma Drug Cuts Attacks Without Recent Crisis

Clinical research that matters. Delivered to your inbox.

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