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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Adrenergic alpha-Agonists [MoA] | MoA | All 85 members |
| Histamine H1 Receptor Antagonists [MoA] | MoA | All 136 members |
| Histamine-1 Receptor Antagonist [EPC] | EPC | All 134 members |
| alpha-Adrenergic Agonist [EPC] | EPC | All 85 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 210507-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | Discontinued | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | September 10, 2024 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260825). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • 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
Purpose
openFDA Drug LabelingPurposes Antihistamine Nasal decongestant
Dosage and Administration
openFDA Drug LabelingDirections • 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
Warnings
openFDA Drug LabelingWarnings 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. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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. Your doctor should determine if you need a different dose. 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 to this product occurs. Seek medical help right away. • 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Do Not Use
openFDA Drug LabelingDo not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a Doctor
openFDA Drug LabelingAsk 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. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: CETIRIZINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 58602-703-09 | 58602-703 | Aurohealth LLC | 12 BLISTER PACK in 1 CARTON (58602-703-09) / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 8, 2023 |
| 58602-703-53 | 58602-703 | Aurohealth LLC | 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 8, 2023 |
| 58602-703-75 | 58602-703 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-703-75) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 8, 2023 |
| 58602-703-76 | 58602-703 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 8, 2023 |
| 45802-147-53 | 45802-147 | Padagis Israel Pharmaceuticals Ltd | 12 BLISTER PACK in 1 CARTON (45802-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 31, 2020 |
| 45802-147-62 | 45802-147 | Padagis Israel Pharmaceuticals Ltd | 24 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 31, 2020 |
| 62756-915-62 | 62756-915 | Sun Pharmaceutical Industries, Inc. | 2 BLISTER PACK in 1 CARTON (62756-915-62) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) | September 29, 2012 |
| 62756-915-73 | 62756-915 | Sun Pharmaceutical Industries, Inc. | 4 BLISTER PACK in 1 CARTON (62756-915-73) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) | September 29, 2012 |
| 29300-313-22 | 29300-313 | Unichem Pharmaceuticals (USA), Inc. | 2 BLISTER PACK in 1 CARTON (29300-313-22) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (29300-313-61) | January 1, 2025 |
| 29300-313-24 | 29300-313 | Unichem Pharmaceuticals (USA), Inc. | 4 BLISTER PACK in 1 CARTON (29300-313-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (29300-313-61) | January 1, 2025 |
| 58602-703 | 58602-703 | Aurohealth LLC | — | March 8, 2023 |
| 45802-147 | 45802-147 | Padagis Israel Pharmaceuticals Ltd | — | March 31, 2020 |
| 62756-915 | 62756-915 | Sun Pharmaceutical Industries, Inc. | — | September 29, 2012 |
| 29300-313 | 29300-313 | Unichem Pharmaceuticals (USA), Inc. | — | September 10, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.