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Fexofenadine HCl and Pseudoephedrine HCI

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 HCl and Pseudoephedrine HCI
Generic name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr. Reddy's Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
8
Packages
17
Data completeness
83% 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, Extended Release
Route of administration
Oral
Presentations
25

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
076667
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 18, 2014
Sponsor
DR REDDYS
Products on application
1
Submissions recorded
2
Products approved under application 076667.
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
Most recent submissions on application 076667.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20181205 HUMAN OTC DRUG · 20171207

Indications and Usage

openFDA Drug Labeling

Use(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 Antihistamine 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 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 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 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 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 Labeling

Active ingredient(s) Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg

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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
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
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
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

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
Enforcement FDA Recall records

Generated September 25, 2026 · 11 sections on this page.