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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, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Wal-mart Stores, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
9
Packages
15
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, Extended Release
Route of administration
Oral
Presentations
24

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
215434
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 31, 2022
Sponsor
DR REDDYS
Products on application
1
Submissions recorded
1
Products approved under application 215434.
Product Trade name Form Strength Ingredient Status TE Flags
215434-001 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 215434.
Type No. Action Status Date Review
Original application 1 Approved May 31, 2022 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251210). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251210 HUMAN OTC DRUG · 20241010 HUMAN OTC DRUG · 20240426

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 relives 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 Labeling

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 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 Labeling

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

openFDA Drug Labeling

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

openFDA Drug Labeling

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

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
51316-015-20 51316-015 CVS Health Corp 4 BLISTER PACK in 1 CARTON (51316-015-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2023
51316-015-30 51316-015 CVS Health Corp 6 BLISTER PACK in 1 CARTON (51316-015-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2023
69842-973-20 69842-973 CVS Pharmacy 1 BLISTER PACK in 1 CARTON (69842-973-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 27, 2020
69842-973-30 69842-973 CVS Pharmacy 1 BLISTER PACK in 1 CARTON (69842-973-30) / 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 27, 2020
30142-097-20 30142-097 Kroger Company 4 BLISTER PACK in 1 CARTON (30142-097-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 1, 2023
41415-995-20 41415-995 PUBLIX SUPER MARKETS, INC 1 BLISTER PACK in 1 CARTON (41415-995-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK November 8, 2021
41415-995-30 41415-995 PUBLIX SUPER MARKETS, INC 1 BLISTER PACK in 1 CARTON (41415-995-30) / 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK November 8, 2021
11822-0021-4 11822-0021 Rite Aid Corporation 4 BLISTER PACK in 1 CARTON (11822-0021-4) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 31, 2023
11822-0021-6 11822-0021 Rite Aid Corporation 6 BLISTER PACK in 1 CARTON (11822-0021-6) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 23, 2023
53360-1111-0 53360-1111 Sanofi Winthrop Industrie 1 BAG in 1 DRUM (53360-1111-0) / 90000 TABLET, EXTENDED RELEASE in 1 BAG March 3, 2011
70677-1010-1 70677-1010 Strategic Sourcing Services, LLC 4 BLISTER PACK in 1 CARTON (70677-1010-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 5, 2023
79903-108-20 79903-108 Wal-mart Stores, Inc. 4 BLISTER PACK in 1 CARTON (79903-108-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2023
79903-108-30 79903-108 Wal-mart Stores, Inc. 6 BLISTER PACK in 1 CARTON (79903-108-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2023
0363-0044-20 0363-0044 Walgreens Company 4 BLISTER PACK in 1 CARTON (0363-0044-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 31, 2023
0363-0044-30 0363-0044 Walgreens Company 6 BLISTER PACK in 1 CARTON (0363-0044-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 31, 2023
51316-015 51316-015 CVS Health Corp — June 3, 2022
69842-973 69842-973 CVS Pharmacy — August 27, 2020
30142-097 30142-097 Kroger Company — March 31, 2022
41415-995 41415-995 PUBLIX SUPER MARKETS, INC — November 8, 2021
11822-0021 11822-0021 Rite Aid Corporation — March 31, 2022
53360-1111 53360-1111 Sanofi Winthrop Industrie — March 3, 2011
70677-1010 70677-1010 Strategic Sourcing Services, LLC — March 31, 2022
79903-108 79903-108 Wal-mart Stores, Inc. — March 31, 2022
0363-0044 0363-0044 Walgreens Company — March 31, 2022

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.