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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Generic name
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
WALGREEN CO.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
16
Packages
35
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Fexofenadine Hydrochloride 180 mg/1 997501 View
Fexofenadine Hydrochloride 60 mg/1 997501 View
Pseudoephedrine Hydrochloride 120 mg/1 1305603 View
Pseudoephedrine Hydrochloride 240 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
51

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
090818
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 29, 2015
Sponsor
SUN PHARM
Products on application
1
Submissions recorded
2
Products approved under application 090818.
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
Most recent submissions on application 090818.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20251113 HUMAN OTC DRUG · 20250418 HUMAN OTC DRUG · 20250311 HUMAN OTC DRUG · 20180718

Indications and Usage

openFDA Drug Labeling

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 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

Active 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 Labeling

Directions 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 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 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 Labeling

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.

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.

Active Ingredient

openFDA Drug Labeling

Active 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 FAERS
36,595
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.