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Allegra-D Allergy and Congestion

fexofenadine hydrochloride and pseudoephedrine hydrochloride · Tablet, Film Coated, Extended Release

Over-the-counter NDA RLD 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
Allegra-D Allergy and Congestion
Generic name
fexofenadine hydrochloride and pseudoephedrine hydrochloride
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Chattem, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
5
Data completeness
76% 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
7

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
020786
Application type
NDA · New Drug Application
Approval date
December 24, 1997
Sponsor
CHATTEM SANOFI
Products on application
1
Submissions recorded
25
Products approved under application 020786.
Product Trade name Form Strength Ingredient Status TE Flags
020786-002 ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION TABLET, EXTENDED RELEASE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020786.
Type No. Action Status Date Review
Supplement 39 Manufacturing (CMC) Approved October 31, 2016 Standard
Supplement 36 Manufacturing (CMC) Approved October 31, 2016 Standard
Supplement 35 Labeling Approved June 2, 2016 Standard
Supplement 34 Manufacturing (CMC) Approved July 9, 2015 Standard
Supplement 33 Efficacy Approved June 8, 2015 Standard
Supplement 32 Manufacturing (CMC) Approved May 14, 2014 Standard
Supplement 31 Labeling Approved December 5, 2012 Standard
Supplement 29 Labeling Approved August 23, 2012 Standard
Supplement 28 Manufacturing (CMC) Approved February 3, 2012 Standard
Supplement 27 Efficacy Approved January 24, 2011 Standard
Supplement 26 Labeling Approved April 14, 2010 Unknown
Supplement 17 Labeling Approved December 6, 2004 Standard
Supplement 14 Efficacy Approved May 12, 2003 Priority
Supplement 12 Labeling Approved November 1, 2002 Standard
Supplement 11 Manufacturing (CMC) Approved October 29, 2002 Standard
Supplement 13 Manufacturing (CMC) Approved October 31, 2001 Standard
Supplement 9 Manufacturing (CMC) Approved January 19, 2001 Standard
Supplement 8 Manufacturing (CMC) Approved September 26, 2000 Standard
Supplement 4 Manufacturing (CMC) Approved January 21, 2000 Standard
Supplement 6 Manufacturing (CMC) Approved January 6, 2000 Standard
Supplement 2 Manufacturing (CMC) Approved December 21, 1999 Standard
Supplement 5 Manufacturing (CMC) Approved December 1, 1999 Standard
Supplement 3 Labeling Approved December 22, 1998 Standard
Supplement 1 Manufacturing (CMC) Approved July 6, 1998 Standard
Original application 1 Type 4 - New Combination Approved December 24, 1997 Standard

Review documents

  • 0 · Supplement · June 10, 2016
  • 0 · Supplement · June 7, 2016
  • 0 · Supplement · June 19, 2015
  • 0 · Supplement · June 10, 2015
  • 0 · Supplement · January 8, 2013
  • 0 · Supplement · December 11, 2012
  • 0 · Supplement · October 12, 2012
  • 0 · Supplement · August 27, 2012
  • 0 · Supplement · March 27, 2012
  • 0 · Supplement · February 13, 2012
  • 0 · Supplement · January 27, 2011
  • 0 · Original application · May 25, 2010
  • 0 · Supplement · April 19, 2010
  • 0 · Supplement · April 19, 2010
  • 0 · Supplement · August 8, 2008
  • 0 · Supplement · August 8, 2008
  • 0 · Supplement · August 8, 2008
  • 0 · Supplement · August 8, 2008
  • 0 · Supplement · August 4, 2008
  • 0 · Supplement · August 4, 2008
  • 0 · Supplement · August 4, 2008
  • 0 · Supplement · August 6, 2007
  • 0 · Supplement · June 8, 2003
  • 0 · Supplement · May 29, 2003
  • 0 · Supplement · November 1, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260112). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260112

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Purpose 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

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 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.

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) Fexofenadine HCl 180 mg

Active ingredients (in each extended-release tablet) Pseudoephedrine HCl 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.

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
41167-4310-2 41167-4310 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-4310-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK March 3, 2011
41167-4310-4 41167-4310 Chattem, Inc. 2 BLISTER PACK in 1 CARTON (41167-4310-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK March 3, 2011
41167-4310-6 41167-4310 Chattem, Inc. 3 BLISTER PACK in 1 CARTON (41167-4310-6) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK March 3, 2011
41167-4320-5 41167-4320 Chattem, Inc. 2 BLISTER PACK in 1 CARTON (41167-4320-5) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK March 3, 2011
41167-4320-7 41167-4320 Chattem, Inc. 3 BLISTER PACK in 1 CARTON (41167-4320-7) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK March 3, 2011
41167-4310 41167-4310 Chattem, Inc. — March 3, 2011
41167-4320 41167-4320 Chattem, Inc. — March 3, 2011

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.