Overview
Pseudoephedrine is structurally related to ephedrine but exerts a weaker effect on the sympathetic nervous system. Both drugs naturally occur in in ephedra plant which have a history of use in traditional Eastern medicine and were first researched in the west in 1889. The decongestant effect of pseudoephedrine was described in dogs in 1927.
Indication
Pseudoephedrine is a sympathomimetic amine used for its decongestant activity.
Associated Conditions
- Allergic Reaction
- Allergic Rhinitis (AR)
- Common Cold
- Common Cold Associated With Cough
- Cough
- Cough caused by Common Cold
- Eye allergy
- Fever
- Flu caused by Influenza
- Headache
- Irritative cough
- Nasal Allergies
- Nasal Congestion
- Nasal Congestion caused by Common Cold
- Pain
- Perennial Allergy
- Priapism
- Respiratory Allergy
- Rhinorrhoea
- Seasonal Allergic Rhinitis
- Seasonal Allergies
- Sinus Congestion
- Sinusitis
- Sneezing
- Sore Throat
- Symptoms of Acute Bronchitis Accompanied by Coughing
- Throat irritation
- Upper Respiratory Tract Infection
- Upper respiratory tract congestion
- Upper respiratory tract signs and symptoms
- Cold or flu syndrome
- Dry cough
- Minor aches and pains
- Sinus pain
- Watery itchy eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/25 | Not Applicable | Recruiting | |||
2023/01/20 | Not Applicable | Completed | |||
2020/12/23 | Not Applicable | Completed | |||
2020/04/02 | Phase 4 | Completed | |||
2018/08/23 | Phase 1 | Completed | |||
2017/06/14 | Phase 1 | Completed | |||
2014/07/08 | Phase 1 | Completed | |||
2014/07/08 | Phase 3 | Completed | |||
2014/05/29 | Early Phase 1 | Terminated | |||
2013/08/20 | Phase 1 | Completed | Cuneyt M. Alper |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cardinal Health 110, LLC. dba Leader | 70000-0605 | ORAL | 120 mg in 1 1 | 4/25/2025 | |
| Proficient Rx LP | 63187-930 | ORAL | 30 mg in 5 mL | 4/1/2022 | |
| Strategic Sourcing Services LLC | 70677-1017 | ORAL | 30 mg in 1 1 | 4/9/2025 | |
| Major Pharmaceuticals | 0904-6990 | ORAL | 30 mg in 1 1 | 4/9/2025 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4165 | ORAL | 30 mg in 5 mL | 2/20/2018 | |
| STAT RX USA LLC | 16590-852 | ORAL | 240 mg in 1 1 | 12/15/2009 | |
| Bryant Ranch Prepack | 72162-1123 | ORAL | 30 mg in 5 mL | 8/17/2023 | |
| Strategic Sourcing Services LLC | 70677-1278 | ORAL | 120 mg in 1 1 | 5/9/2025 | |
| Meijer Distribution Inc | 41250-954 | ORAL | 120 mg in 1 1 | 5/28/2025 | |
| Physicians Total Care, Inc. | 54868-5419 | ORAL | 240 mg in 1 1 | 9/25/2012 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| POLARINE TABLET | SIN07612P | TABLET | 60 mg | 1/18/1994 | |
| CLARITYN-D 12HOUR REPETABS | SIN07282P | TABLET, SUGAR COATED | 120 mg | 11/6/1992 | |
| FEBRICOL TABLET | SIN11488P | TABLET | 30 mg | 4/11/2001 | |
| DECONDINE SYRUP | SIN03181P | SYRUP | 30 mg/5 ml | 6/12/1989 | |
| ZYRTEC-D | SIN13139P | TABLET, FILM COATED | 120 MG | 7/4/2005 | |
| COLDSOFT NIGHT SOFT GELATIN CAPSULE | SIN13439P | CAPSULE, GELATIN COATED | 31.50MG | 4/9/2008 | |
| POLARINE SYRUP | SIN03182P | SYRUP | 30 mg/5 ml | 5/31/1989 | |
| ROBITUSSIN PS SYRUP | INTERPHIL LABORATORIES INC | SIN12223P | SYRUP | 60 mg/10 ml | 3/7/2003 |
| PSEUDORINE TABLETS 60 mg | SIN03178P | TABLET | 60 mg | 6/8/1989 | |
| PEACEF SYRUP 30 mg/5 ml | SIN11124P | SYRUP | 30 mg/5 ml | 9/25/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SINIFED TAB | N/A | N/A | N/A | 5/11/2012 | |
| BECAME TAB | N/A | N/A | N/A | 1/8/1991 | |
| AERIUS D-12 MODIFIED RELEASE TAB | N/A | N/A | N/A | 10/30/2009 | |
| SINOCON TABLET | N/A | N/A | N/A | 11/13/2014 | |
| VASOCEDINE PSEUDOEPHEDRINE TABLETS 60MG | N/A | N/A | N/A | 12/8/2016 | |
| ZYRTEC-D PROLONGED RELEASE TAB | N/A | N/A | N/A | 3/14/2005 | |
| ZUDO TAB 60MG | N/A | N/A | N/A | 2/9/2009 | |
| UNI-FEDRA COMPOUND SYRUP | N/A | N/A | N/A | 6/22/1990 | |
| UNI-FEDRA TABLET | N/A | N/A | N/A | 5/2/2013 | |
| TELFAST D TAB | N/A | N/A | N/A | 10/27/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DEMAZIN ORIGINAL COLD + FLU RELIEF DAY + NIGHT tablet blister pack | 286002 | Medicine | A | 2/22/2017 | |
| TELFAST DECONGESTANT tablet blister pack | 72552 | Medicine | A | 1/20/2000 | |
| NOUMED SINUS + PAIN RELIEF PSE tablet blister pack | 303657 | Medicine | A | 5/29/2018 | |
| APOHEALTH COLD & FLU RELIEF DAY/NIGHT uncoated tablet blister pack | 236266 | Medicine | A | 4/16/2015 | |
| TRUST SINUS & NASAL DECONGESTANT pseudoephedrine hydrochloride 60 mg tablet blister pack | 233000 | Medicine | A | 1/21/2015 | |
| NOUMED COLD & FLU RELIEF tablet blister pack | 67988 | Medicine | A | 3/9/1999 | |
| LOGICIN HAY FEVER tablet blister pack | 54165 | Medicine | A | 12/12/1995 | |
| CLARATYNE-D WITH DECONGESTANT tablets blister pack | 53516 | Medicine | A | 9/21/1995 | |
| SUDAFED SINUS + PAIN RELIEF DAY & NIGHT uncoated tablet blister pack | 46869 | Medicine | A | 10/26/1993 | |
| CODRAL ORIGINAL DAY & NIGHT uncoated tablet blister pack | 275261 | Medicine | A | 5/11/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CHILDREN'S ADVIL COLD | glaxosmithkline consumer healthcare ulc | 02248435 | Suspension - Oral | 15 MG / 5 ML | 8/9/2004 |
| ROBITUSSIN COUGH, COLD & FLU LIQUI-GELS | wyeth consumer healthcare inc. | 02161672 | Capsule - Oral | 30 MG | 12/31/1995 |
| SINUS MEDICATION EXTRA STRENGTH NIGHT TIME | 02246847 | Tablet - Oral | 30 MG | 12/8/2002 | |
| COLD MEDICATION REGULAR NIGHTTIME TABLETS | cellchem pharmaceuticals inc. | N/A | Tablet - Oral | 30 MG | N/A |
| CALMYLIN COUGH AND FLU LIQ | technilab pharma inc. | 01978314 | Liquid - Oral | 30 MG / 15 ML | 12/31/1992 |
| ADVIL COLD & SINUS PLUS | haleon canada ulc | N/A | Tablet - Oral | 30 MG | 8/2/2004 |
| ADVIL COLD, SINUS & FLU EXTRA STRENGTH | haleon canada ulc | 02471604 | Tablet - Oral | 60 MG | 8/17/2018 |
| VASOFRINIC DH | laboratoires trianon inc. | 00472549 | Syrup - Oral | 30 MG / 5 ML | 12/31/1979 |
| A.M. COLD RELIEF FORMULA | ivax pharmaceuticals incorporated | 02262312 | Capsule - Oral | 30 MG | N/A |
| NYQUIL LIQUICAPS | procter & gamble inc | 01996215 | Capsule - Oral | 30 MG / CAP | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| VINCIGRIP CAPSULAS DURAS | Laboratorios Salvat S.A. | 59239 | CÁPSULA DURA | Sin Receta | Commercialized |
| VINCIGRIP FORTE GRANULADO PARA SOLUCION ORAL SABOR CACAO | Laboratorios Salvat S.A. | 60897 | GRANULADO PARA SOLUCIÓN ORAL | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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