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allergy relief d
cetirizine hydrochloride, pseudoephedrine hydrochloride · Tablet, Film Coated, Extended Release
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 |
|---|---|---|---|---|---|---|---|
| 210719-001 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | November 16, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250212). 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: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose
Purpose
openFDA Drug LabelingPurpose 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 pregnancy 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.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs
Active Ingredient
openFDA Drug LabelingActive ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 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 |
|---|---|---|---|---|
| 69842-415-53 | 69842-415 | CVS Pharmacy | 12 BLISTER PACK in 1 CARTON (69842-415-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2020 |
| 69842-415-62 | 69842-415 | CVS Pharmacy | 24 BLISTER PACK in 1 CARTON (69842-415-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2020 |
| 37808-651-53 | 37808-651 | H E B | 12 BLISTER PACK in 1 CARTON (37808-651-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | February 24, 2021 |
| 37808-651-62 | 37808-651 | H E B | 24 BLISTER PACK in 1 CARTON (37808-651-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | February 18, 2021 |
| 41250-954-60 | 41250-954 | Meijer Distribution Inc | 20 BLISTER PACK in 1 CARTON (41250-954-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | June 12, 2018 |
| 56062-147-53 | 56062-147 | Publix Super Markets Inc | 12 BLISTER PACK in 1 CARTON (56062-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | February 12, 2021 |
| 56062-147-62 | 56062-147 | Publix Super Markets Inc | 24 BLISTER PACK in 1 CARTON (56062-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | February 16, 2021 |
| 56062-555-46 | 56062-555 | Publix Super Markets Inc | 10 BLISTER PACK in 1 CARTON (56062-555-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 23, 2018 |
| 56062-555-60 | 56062-555 | Publix Super Markets Inc | 20 BLISTER PACK in 1 CARTON (56062-555-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 23, 2018 |
| 11822-1055-0 | 11822-1055 | Rite Aid Corporation | 10 BLISTER PACK in 1 CARTON (11822-1055-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 5, 2020 |
| 11822-1055-1 | 11822-1055 | Rite Aid Corporation | 30 BLISTER PACK in 1 CARTON (11822-1055-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | December 21, 2022 |
| 69842-415 | 69842-415 | CVS Pharmacy | — | April 1, 2020 |
| 37808-651 | 37808-651 | H E B | — | February 18, 2021 |
| 41250-954 | 41250-954 | Meijer Distribution Inc | — | June 12, 2018 |
| 56062-147 | 56062-147 | Publix Super Markets Inc | — | February 12, 2020 |
| 56062-555 | 56062-555 | Publix Super Markets Inc | — | April 23, 2018 |
| 11822-1055 | 11822-1055 | Rite Aid Corporation | — | May 5, 2020 |
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.