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Fexofenadine HCl and Pseudoephedrine HCI
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 |
|---|---|---|---|---|---|---|---|
| 076667-001 | 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 | 3 | Labeling | Approved | January 26, 2016 | Standard |
| Original application | 1 | Approved | November 18, 2014 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20181205). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse(s) 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 LabelingPurpose Antihistamine 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 12 hours on an empty stomach; do not take more than 2 tablets 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
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) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions). Stop use and ask 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.
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 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
Active Ingredient
openFDA Drug LabelingActive ingredient(s) Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg
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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class III | January 26, 2022 | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications | Terminated |
| Class III | January 26, 2022 | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications | Terminated |
| Class III | December 15, 2021 | Dr. Reddy's Laboratories, Inc. | Failed dissolution specifications | Terminated |
| Class III | December 15, 2021 | Dr. Reddy's Laboratories, Inc. | Failed dissolution specifications | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 59779-508-14 | 59779-508 | CVS Pharmacy | 4 BLISTER PACK in 1 CARTON (59779-508-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 19, 2014 |
| 59779-508-31 | 59779-508 | CVS Pharmacy | 6 BLISTER PACK in 1 CARTON (59779-508-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 19, 2014 |
| 43598-823-14 | 43598-823 | Dr. Reddy's Laboratories Inc. | 4 BLISTER PACK in 1 CARTON (43598-823-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 18, 2019 |
| 43598-823-31 | 43598-823 | Dr. Reddy's Laboratories Inc. | 6 BLISTER PACK in 1 CARTON (43598-823-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 18, 2019 |
| 43598-823-35 | 43598-823 | Dr. Reddy's Laboratories Inc. | 2 BLISTER PACK in 1 CARTON (43598-823-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 31, 2019 |
| 43598-823-40 | 43598-823 | Dr. Reddy's Laboratories Inc. | 35 TABLET, EXTENDED RELEASE in 1 CARTON (43598-823-40) | October 19, 2022 |
| 55111-447-14 | 55111-447 | Dr. Reddy's Laboratories Limited | 4 BLISTER PACK in 1 CARTON (55111-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | November 18, 2014 |
| 55111-447-31 | 55111-447 | Dr. Reddy's Laboratories Limited | 6 BLISTER PACK in 1 CARTON (55111-447-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | November 18, 2014 |
| 55111-447-35 | 55111-447 | Dr. Reddy's Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-447-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | November 18, 2014 |
| 55111-557-07 | 55111-557 | Dr.Reddy's Laboratories Limited | 1 BLISTER PACK in 1 CARTON (55111-557-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 24, 2011 |
| 55111-557-29 | 55111-557 | Dr.Reddy's Laboratories Limited | 3 BLISTER PACK in 1 CARTON (55111-557-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 24, 2011 |
| 55111-557-35 | 55111-557 | Dr.Reddy's Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-557-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 24, 2011 |
| 37808-022-31 | 37808-022 | HEB | 6 BLISTER PACK in 1 CARTON (37808-022-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 21, 2015 |
| 30142-447-14 | 30142-447 | The Kroger Co. | 4 BLISTER PACK in 1 CARTON (30142-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 22, 2015 |
| 30142-611-14 | 30142-611 | The Kroger Co. | 4 BLISTER PACK in 1 CARTON (30142-611-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 15, 2019 |
| 0363-1606-20 | 0363-1606 | Walgreens Company | 4 BLISTER PACK in 1 CARTON (0363-1606-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | September 16, 2019 |
| 0363-1606-30 | 0363-1606 | Walgreens Company | 6 BLISTER PACK in 1 CARTON (0363-1606-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | September 16, 2019 |
| 59779-508 | 59779-508 | CVS Pharmacy | — | November 19, 2014 |
| 43598-823 | 43598-823 | Dr. Reddy's Laboratories Inc. | — | October 19, 2022 |
| 55111-447 | 55111-447 | Dr. Reddy's Laboratories Limited | — | November 18, 2014 |
| 55111-557 | 55111-557 | Dr.Reddy's Laboratories Limited | — | August 24, 2011 |
| 37808-022 | 37808-022 | HEB | — | December 21, 2015 |
| 30142-447 | 30142-447 | The Kroger Co. | — | April 22, 2015 |
| 30142-611 | 30142-611 | The Kroger Co. | — | January 15, 2019 |
| 0363-1606 | 0363-1606 | Walgreens Company | — | September 16, 2019 |
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 |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 11 sections on this page.