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Fexofenadine 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 |
|---|---|---|---|---|---|---|---|
| 090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Labeling | Approved | January 26, 2016 | Standard |
| Original application | 1 | Approved | January 29, 2015 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251113). 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 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 LabelingActive ingredients (in each extended-release tablet) Purpose Fexofenadine HCl, USP 60 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant
Dosage and Administration
openFDA Drug LabelingDirections do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20° and 25°C (68° and 77°F) FDA approved dissolution test specifications differ from USP
Warnings
openFDA Drug LabelingWarnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) Stop 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 you get nervous, dizzy, or sleepless If pregnant or breast-feeding, 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 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. if you have difficulty swallowing
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland 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 you get nervous, dizzy, or sleepless If pregnant or breast-feeding, ask a health professional before use.
Active Ingredient
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Purpose Fexofenadine HCl, USP 60 mg Antihistamine Pseudoephedrine HCl, USP 120 mg Nasal Decongestant
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: PSEUDOEPHEDRINE 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 |
|---|---|---|---|---|
| 46122-694-65 | 46122-694 | AmeriSource Bergen | 3 BLISTER PACK in 1 CARTON (46122-694-65) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 59651-033-99 | 59651-033 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-033-99) | October 30, 2017 |
| 59651-454-31 | 59651-454 | Aurobindo Pharma Limited | 30000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-454-31) | April 17, 2025 |
| 59651-454-99 | 59651-454 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (59651-454-99) | April 17, 2025 |
| 58602-807-67 | 58602-807 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-807-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | October 30, 2017 |
| 58602-807-83 | 58602-807 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-807-83) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | October 30, 2017 |
| 58602-807-84 | 58602-807 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-807-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | October 30, 2017 |
| 58602-844-60 | 58602-844 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-844-60) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 17, 2025 |
| 58602-844-66 | 58602-844 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-844-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 17, 2025 |
| 58602-844-85 | 58602-844 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-844-85) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | April 17, 2025 |
| 69842-990-20 | 69842-990 | CVS Pharmacy | 1 BLISTER PACK in 1 CARTON (69842-990-20) / 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 69842-990-30 | 69842-990 | CVS Pharmacy | 1 BLISTER PACK in 1 CARTON (69842-990-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 51316-007-67 | 51316-007 | CVS Pharmacy, Inc. | 2 BLISTER PACK in 1 CARTON (51316-007-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2022 |
| 51316-007-84 | 51316-007 | CVS Pharmacy, Inc. | 3 BLISTER PACK in 1 CARTON (51316-007-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | November 17, 2022 |
| 70000-0677-1 | 70000-0677 | Cardinal Health | 2 BLISTER PACK in 1 CARTON (70000-0677-1) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 15, 2024 |
| 70000-0677-2 | 70000-0677 | Cardinal Health | 3 BLISTER PACK in 1 CARTON (70000-0677-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 15, 2024 |
| 37808-999-30 | 37808-999 | H E B | 1 BLISTER PACK in 1 CARTON (37808-999-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | August 1, 2018 |
| 30142-059-20 | 30142-059 | KROGER COMPANY | 2 BLISTER PACK in 1 CARTON (30142-059-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 18, 2024 |
| 30142-059-84 | 30142-059 | KROGER COMPANY | 3 BLISTER PACK in 1 CARTON (30142-059-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 15, 2021 |
| 51660-037-21 | 51660-037 | Ohm Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (51660-037-21) / 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 51660-037-31 | 51660-037 | Ohm Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (51660-037-31) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 0536-1431-07 | 0536-1431 | Rugby Laboratories | 3 BLISTER PACK in 1 CARTON (0536-1431-07) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 17, 2024 |
| 0536-1431-34 | 0536-1431 | Rugby Laboratories | 2 BLISTER PACK in 1 CARTON (0536-1431-34) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | May 17, 2024 |
| 47335-724-64 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | March 1, 2018 |
| 47335-724-66 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 2 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | March 1, 2018 |
| 47335-724-75 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 4 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | March 1, 2018 |
| 47335-724-83 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83) | March 1, 2018 |
| 47335-724-94 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 1 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 47335-724-95 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 3 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 47335-724-99 | 47335-724 | Sun Pharmaceutical Industries, Inc. | 2 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 0363-0094-67 | 0363-0094 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-0094-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | October 30, 2017 |
| 0363-0094-84 | 0363-0094 | WALGREEN CO. | 3 BLISTER PACK in 1 CARTON (0363-0094-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | October 30, 2017 |
| 0363-0270-10 | 0363-0270 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-0270-10) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | August 27, 2026 |
| 0363-2110-20 | 0363-2110 | walgreens | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-20) | April 17, 2018 |
| 0363-2110-30 | 0363-2110 | walgreens | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-2110-30) | April 17, 2018 |
| 46122-694 | 46122-694 | AmeriSource Bergen | — | March 1, 2018 |
| 59651-033 | 59651-033 | Aurobindo Pharma Limited | — | October 30, 2017 |
| 59651-454 | 59651-454 | Aurobindo Pharma Limited | — | April 17, 2025 |
| 58602-807 | 58602-807 | Aurohealth LLC | — | October 30, 2017 |
| 58602-844 | 58602-844 | Aurohealth LLC | — | April 17, 2025 |
| 69842-990 | 69842-990 | CVS Pharmacy | — | March 1, 2018 |
| 51316-007 | 51316-007 | CVS Pharmacy, Inc. | — | November 17, 2022 |
| 70000-0677 | 70000-0677 | Cardinal Health | — | May 15, 2024 |
| 37808-999 | 37808-999 | H E B | — | August 1, 2018 |
| 30142-059 | 30142-059 | KROGER COMPANY | — | March 15, 2021 |
| 51660-037 | 51660-037 | Ohm Laboratories Inc. | — | March 1, 2018 |
| 0536-1431 | 0536-1431 | Rugby Laboratories | — | May 17, 2024 |
| 47335-724 | 47335-724 | Sun Pharmaceutical Industries, Inc. | — | March 1, 2018 |
| 0363-0094 | 0363-0094 | WALGREEN CO. | — | October 30, 2017 |
| 0363-0270 | 0363-0270 | WALGREEN CO. | — | August 27, 2026 |
| 0363-2110 | 0363-2110 | walgreens | — | April 17, 2018 |
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 · 11 sections on this page.