Allegra-D

Allegra-D is a branded fixed-dose combination medicine used for the temporary relief of allergy symptoms accompanied by nasal congestion. Its two active ingredients are fexofenadine hydrochloride, a relatively non-sedating H1 antihistamine, and pseudoephedrine hydrochloride, an oral nasal decongestant. The product is marketed as part of the broader Allegra allergy-relief franchise and is distinguished from standard Allegra products by the addition of pseudoephedrine, represented by the letter “D.” The brand originated in the United States during the development of fexofenadine-based allergy treatments. The original Allegra-D formulation combined 60 mg of fexofenadine hydrochloride with 120 mg of pseudoephedrine hydrochloride in an extended-release tablet. U.S. regulatory documentation identifies the product as having been developed and submitted by Hoechst Marion Roussel, the predecessor organization associated with the later Aventis and Sanofi businesses. The original Allegra-D combination was approved in the late 1990s, with an FDA environmental assessment for the 60 mg/120 mg product dated December 3, 1997. A higher-strength once-daily Allegra-D 24 Hour formulation, containing 180 mg of fexofenadine and 240 mg of pseudoephedrine, received FDA approval on October 19, 2004 and was introduced commercially in 2005. Allegra-D is positioned for consumers who need both antihistamine treatment and relief from nasal blockage. Fexofenadine addresses symptoms such as sneezing, runny nose, itchy nose or throat, and itchy or watery eyes. Pseudoephedrine reduces swelling in the nasal passages and helps relieve sinus pressure and congestion. The combination therefore occupies a narrower but more functionally complete position than stand-alone non-drowsy antihistamine products. Both 12-hour and 24-hour extended-release versions have been marketed in the United States. In the United States, Allegra-D is sold through pharmacies and is subject to restrictions associated with pseudoephedrine sales. Although the product is generally available without a conventional prescription in most states, it is commonly kept behind the pharmacy counter or otherwise controlled under federal and state requirements. The Allegra website notes that prescription requirements differ in Mississippi and Oregon. The product labeling is intended for adults and children aged 12 years and older, and the tablets are designed to be swallowed whole rather than crushed, chewed, divided, or dissolved. The brand has remained connected to Sanofi's consumer-health operations through several corporate stages. It was initially associated with Hoechst Marion Roussel and Aventis, later with Sanofi-aventis and Sanofi Consumer Healthcare, and, after Sanofi's 2025 divestment of control of its consumer-health business, with Opella. On April 30, 2025, Opella became an independent consumer-health company under the control of Clayton, Dubilier & Rice, while Sanofi retained a substantial minority interest. Opella continues to identify Allegra among its global brands. Allegra-D's commercial identity emphasizes fast-acting, long-lasting, and non-drowsy allergy relief, although the pseudoephedrine component can produce stimulant-type effects and carries additional warnings and purchase restrictions. The brand is therefore marketed as a targeted solution for allergy sufferers whose symptoms include congestion rather than as a general-purpose daily antihistamine. Current U.S. products include Allegra-D Allergy & Congestion 12 Hour Tablets and Allegra-D Allergy & Congestion 24 Hour Tablets. The brand remains active, but its specific labeling, manufacturer-of-record information, availability, and pharmacy restrictions can vary by country and product presentation.

Allegra-D developed from the broader Allegra fexofenadine franchise and from the commercial need to combine an effective, comparatively non-sedating antihistamine with an established oral decongestant. Fexofenadine itself is the active antihistaminic metabolite associated with terfenadine, while pseudoephedrine had already been used for many years in over-the-counter congestion medicines. The Allegra-D concept joined the two ingredients in an extended-release tablet so that consumers could address allergy symptoms and nasal obstruction with one product. The first U.S. regulatory materials identify Hoechst Marion Roussel, Inc. as the applicant for the original Allegra-D combination. An FDA environmental assessment dated December 3, 1997 described ALLEGRA-D tablets containing 60 mg of fexofenadine hydrochloride and 120 mg of pseudoephedrine hydrochloride. The product was indicated for seasonal allergic rhinitis symptoms and temporary relief of nasal congestion. This approval established the 12-hour product architecture that later became known as Allegra-D 12 Hour. The brand's pharmacological proposition was straightforward. Fexofenadine was intended to relieve sneezing, rhinorrhea, itching, and watery eyes, while pseudoephedrine narrowed blood vessels in the nasal passages and reduced congestion. The combination was aimed at people for whom a conventional antihistamine was insufficient because nasal blockage was a prominent symptom. Extended-release delivery also gave the product a longer duration than immediate-release decongestant tablets. A major turning point came with the development of the higher-strength Allegra-D 24 Hour formulation. The FDA approval history records October 19, 2004 as the first approval date for Allegra-D 24 Hour, containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride. Sanofi-aventis announced its commercial availability in July 2005. This version extended the brand's convenience proposition from twice-daily treatment to once-daily dosing and strengthened the product's role as a dedicated allergy-and-congestion medicine. During the 2000s, the product family was marketed under the corporate succession from Hoechst Marion Roussel to Aventis and then Sanofi-aventis. The brand was associated with the wider Allegra platform, whose central promise emphasized allergy relief without the drowsiness commonly associated with older antihistamines. Allegra-D added the more specialized claim of congestion relief, but it also introduced the regulatory and purchasing complications linked to pseudoephedrine. The U.S. regulatory history continued to evolve. FDA supplements approved in June 2015 added relief of nasal congestion due to the common cold to the Uses section of the Drug Facts labeling for the 12-hour and 24-hour Allegra-D products. Later consumer labeling continued to describe relief of hay-fever and other upper-respiratory-allergy symptoms, reduction of nasal-passage swelling, temporary relief of sinus congestion and pressure, and restoration of freer nasal breathing. Labeling generally directs adults and children aged 12 and older to use the product and warns against crushing or chewing the extended-release tablets. Allegra-D's sales channel is shaped by pseudoephedrine regulation. In the United States, products containing pseudoephedrine are subject to federal purchase limits, recordkeeping, and pharmacy-control requirements. The Allegra consumer site states that Allegra-D is available without a prescription in most states but requires a prescription in Mississippi and Oregon. This makes Allegra-D different from ordinary shelf-accessible antihistamines such as standard fexofenadine products, even though both sit within the same allergy-relief family. Marketing has generally connected Allegra-D to an active lifestyle and the idea of continuing normal activities despite allergies and congestion. A 2020 “Say Yes” campaign used activity-oriented creative to present the product as enabling consumers to participate in plans that allergy symptoms might otherwise disrupt. The broader Allegra franchise has also been marketed in international markets through localized allergy-awareness and consumer-engagement campaigns, although the exact composition and regulatory status of products sold under Allegra or Allegra-D names vary by country. Corporate ownership changed again in 2025. Sanofi separated its consumer-health business into Opella and sold Clayton, Dubilier & Rice a 50% controlling stake. Sanofi retained 48.2% through an indirect holding and Bpifrance acquired 1.8%. Opella became the operating home for a portfolio that includes Allegra, and its headquarters are in France. In North America, legacy Sanofi Consumer Healthcare and Chattem structures remain relevant to U.S. product labeling and commercialization. Today, Allegra-D remains an active sub-brand within the Allegra portfolio. Its core offer has changed little: an extended-release combination of fexofenadine and pseudoephedrine designed for allergy sufferers who also need meaningful relief from nasal congestion. The principal commercial variants are Allegra-D 12 Hour and Allegra-D 24 Hour. The brand's future development is likely to be shaped less by radical reformulation than by consumer-health portfolio management, pharmacy regulation, ingredient controls, and the continuing transition of Sanofi's former consumer-health assets into Opella.

• 2026

  Allegra-D remains listed in FDA product materials

  [5]FDA current Approved Drug Product List, June 2026fda.gov

  The FDA's June 2026 Approved Drug Product List continued to identify Allegra-D 12 Hour Allergy and Congestion as an OTC product.

• 2025

  Opella becomes an independent consumer-health company

  [9]Opella becomes independent in 2025opella.com

  After CD&R acquired a controlling stake in Opella, Allegra became part of the portfolio of the newly independent consumer-health company.

• 2020

  “Say Yes” advertising campaign

  [14]Allegra-D “Say Yes” advertising recordispot.tv

  Allegra-D advertising emphasized remaining active and pursuing everyday plans despite allergy and congestion symptoms.

• 2015

  Common-cold congestion indication added to labeling

  [4]FDA 2021 correspondence concerning Allegra-D labeling and pediatric requirementsfda.gov

  FDA-approved supplements added relief of nasal congestion due to the common cold to the Uses section for the 12-hour and 24-hour products.

• 2005

  24-hour product launched in the United States

  [12]Sanofi announcement of Allegra-D 24 Hour availabilitynews.sanofi.us

  Sanofi-aventis announced the commercial availability of Allegra-D 24 Hour extended-release tablets.

• 2004

  FDA approves Allegra-D 24 Hour

  [11]Allegra-D 24 Hour FDA approval historydrugs.com

  The once-daily 180 mg/240 mg formulation received FDA approval for seasonal allergy symptoms with nasal congestion.

• 1997

  Original 12-hour combination documented in FDA materials

  [3]FDA environmental assessment for original Allegra-Daccessdata.fda.gov

  FDA documentation described Allegra-D tablets combining 60 mg of fexofenadine hydrochloride with 120 mg of pseudoephedrine hydrochloride in an extended-release formulation.

• 1996

  Allegra-D trademark filing

  [13]Allegra-D trademark recordtrademarks.justia.com

  The ALLEGRA-D trademark was filed in the United States for pharmaceutical preparations including antihistamines and decongestants.

A dual-action, non-drowsy allergy and congestion medicine for consumers who need both antihistamine relief and oral nasal decongestion. It is positioned between stand-alone antihistamines and broader cold-and-flu products, with pharmacy-channel restrictions because it contains pseudoephedrine.

• Extended-release antihistamine and nasal decongestant · 1997

  Allegra-D 12 Hour Allergy & Congestion

  The 12-hour product combines fexofenadine hydrochloride 60 mg with pseudoephedrine hydrochloride 120 mg in an extended-release tablet. It is intended for adults and children aged 12 and older who need relief from both upper-respiratory allergy symptoms and nasal congestion. The antihistamine addresses sneezing, runny nose, itchy nose or throat, and itchy or watery eyes, while pseudoephedrine reduces swelling in the nasal passages and relieves congestion. The tablet must be swallowed whole and is subject to U.S. pseudoephedrine purchasing controls.

• Once-daily extended-release antihistamine and nasal decongestant · 2004

  Allegra-D 24 Hour Allergy & Congestion

  The 24-hour version contains fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg. Approved by the FDA in 2004 and commercially introduced in 2005, it was designed to provide once-daily treatment when both allergy relief and nasal decongestion are desired. The product extends the core Allegra-D proposition into a longer-duration format, while retaining the warnings, age restrictions, tablet-handling instructions, and pharmacy-channel controls associated with pseudoephedrine.

• 2020Say Yes

  United States

  The “Say Yes” campaign framed Allegra-D as a way for consumers to continue outdoor activities and everyday plans when allergy symptoms and congestion might otherwise interfere. Its creative approach emphasized energy, participation, and non-drowsy relief.

  Outcome. The campaign became a recognizable U.S. advertising execution for the Allegra-D product line, although publicly available sources do not establish a specific sales or market-share result.

  Source

• 2025

  Transfer of Allegra-D into the independent Opella structureM&A

  Background

  Sanofi decided to separate its consumer-health operations from its focus on innovative medicines and vaccines.

  Action taken

  On April 30, 2025, Clayton, Dubilier & Rice acquired a 50% controlling stake in Opella. Sanofi retained 48.2% and Bpifrance received 1.8%. Allegra was identified as one of Opella's global brands.

  Aftermath

  Allegra-D continued as an active brand within Opella's consumer-health portfolio, while U.S. product labeling continued to reference legacy Sanofi Consumer Healthcare and Chattem structures.

  Ownership of Opella. Opella was controlled by Sanofi → CD&R 50.0% controlling stake; Sanofi 48.2%; Bpifrance 1.8% (April 30, 2025)

  Source

• 2015

  Expansion of labeled congestion usesOther

  Background

  The existing products were already indicated for allergy-related nasal congestion, but FDA labeling supplements addressed congestion associated with the common cold.

  Action taken

  FDA-approved supplements added relief of nasal congestion due to the common cold to the Uses section of the 12-hour and 24-hour Drug Facts labels.

  Aftermath

  The change expanded the labeled symptom context while preserving the product's primary allergy-and-congestion positioning.

  Source

• 2004

  Development of the once-daily Allegra-D 24 Hour formulationGeneration change

  Background

  The brand sought to provide longer-duration coverage for consumers needing both antihistamine and decongestant effects.

  Action taken

  FDA approved a higher-strength extended-release formulation containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride.

  Aftermath

  The 24-hour product broadened Allegra-D's convenience proposition and became a flagship version of the brand.

  Source

• 1997

  Launch of the original Allegra-D combinationProduct launch

  Background

  The Allegra franchise had an antihistamine product, while pseudoephedrine was an established decongestant ingredient. The combination was developed to address allergy symptoms and nasal obstruction in one extended-release tablet.

  Action taken

  The original Allegra-D formulation paired fexofenadine hydrochloride 60 mg with pseudoephedrine hydrochloride 120 mg.

  Aftermath

  The product established the 12-hour Allegra-D format and created a dedicated allergy-and-congestion extension of the Allegra brand.

  Source

1. 1Allegra official U.S. product portfolioallegra.com
2. 2Allegra-D 24 Hour official product informationallegra.com
3. 3FDA environmental assessment for original Allegra-Daccessdata.fda.gov
4. 4FDA 2021 correspondence concerning Allegra-D labeling and pediatric requirementsfda.gov
5. 5FDA current Approved Drug Product List, June 2026fda.gov
6. 6DailyMed Allegra-D 12 Hour labelingdailymed.nlm.nih.gov
7. 7DailyMed Allegra-D 24 Hour labelingdailymed.nlm.nih.gov
8. 8Opella leadershipopella.com
9. 9Opella becomes independent in 2025opella.com
10. 10Sanofi and CD&R close Opella transactionsanofi.com
11. 11Allegra-D 24 Hour FDA approval historydrugs.com
12. 12Sanofi announcement of Allegra-D 24 Hour availabilitynews.sanofi.us
13. 13Allegra-D trademark recordtrademarks.justia.com
14. 14Allegra-D “Say Yes” advertising recordispot.tv