Overview
Histamine H1 antagonist used in treatment of allergies, rhinitis, and urticaria.
Indication
For the treatment of the symptoms of the common cold and allergic rhinitis, such as runny nose, itchy eyes, watery eyes, and sneezing.
Associated Conditions
- Acute nasopharyngitis
- Allergic Reaction
- Allergic Rhinitis (AR)
- Allergy to Tree Pollen
- Common Cold
- Cough
- Cough caused by Common Cold
- Coughing caused by Bronchitis
- Fever
- Flu caused by Influenza
- Headache
- Rhinorrhoea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2011/07/13 | Phase 3 | Completed | Ache Laboratorios Farmaceuticos S.A. | ||
2009/05/07 | Phase 1 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 63187-930 | ORAL | 2 mg in 5 mL | 4/1/2022 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4165 | ORAL | 2 mg in 5 mL | 2/20/2018 | |
| Bryant Ranch Prepack | 72162-1123 | ORAL | 2 mg in 5 mL | 8/17/2023 | |
| Rhodes Pharmaceuticals L.P. | 42858-320 | ORAL | 2 mg in 5 mL | 9/30/2021 | |
| Preferred Pharmaceuticals Inc. | 68788-7975 | ORAL | 2 mg in 5 mL | 1/12/2024 | |
| Morton Grove Pharmaceuticals, Inc. | 60432-275 | ORAL | 2 mg in 5 mL | 12/13/2018 | |
| PAI Holdings, LLC | 0121-0933 | ORAL | 2 mg in 5 mL | 1/24/2024 | |
| Eywa Pharma Inc | 71930-026 | ORAL | 2 mg in 5 mL | 6/26/2020 | |
| Padagis US LLC | 0574-1104 | ORAL | 2 mg in 5 mL | 11/22/2021 | |
| Physicians Total Care, Inc. | 54868-6377 | ORAL | 2 mg in 5 mL | 2/5/2013 |
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 |
|---|---|---|---|---|---|
| BOMEX TABLET 4 mg | SIN10526P | TABLET | 4.0 mg | 12/8/1998 |
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 |
|---|---|---|---|---|---|
| GUSILON COUGH LINCTUS | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 5/17/1982 |
| POURKE CAP | N/A | N/A | N/A | 6/9/2006 | |
| IGLOIE CAP | N/A | N/A | N/A | 7/30/2006 | |
| SANBRON CAP | N/A | N/A | N/A | 1/21/1999 | |
| CODACIN CAP | N/A | N/A | N/A | 5/21/1998 | |
| FIRMBO CAP | N/A | N/A | N/A | 6/9/2006 | |
| MENTA CAP | N/A | N/A | N/A | 12/18/1989 | |
| SINUFORT CAP | N/A | N/A | N/A | 9/11/1979 | |
| NATSIN CAP | N/A | N/A | N/A | 11/18/1980 | |
| COMYLLONE CAP | N/A | N/A | N/A | 11/27/1998 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APOHEALTH CONGESTED COLD & COUGH RELIEF ELIXIR oral liquid bottle | 227533 | Medicine | A | 9/2/2014 | |
| PRICELINE PHARMACY CONGESTED COLD & COUGH oral liquid bottle | 459288 | Medicine | A | 8/13/2024 | |
| DURO-TUSS DRY COUGH & COLD LIQUID NIGHT oral liquid bottle | 465432 | Medicine | A | 10/23/2024 | |
| DIMETAPP COLD & ALLERGY COLOUR FREE oral solution bottle | 59765 | Medicine | A | 4/30/1997 | |
| TERRYWHITE CHEMMART CONGESTED COLD & COUGH oral liquid bottle | 459286 | Medicine | A | 8/13/2024 | |
| DEMAZIN KIDS 6+ COUGH + COLD RELIEF oral liquid bottle | 151700 | Medicine | A | 4/16/2008 | |
| NOUMED CONGESTED COLD & COUGH oral liquid bottle | 81838 | Medicine | A | 3/22/2002 | |
| PHARMACY HEALTH CONGESTED COLD & COUGH oral liquid bottle | 459287 | Medicine | A | 8/13/2024 | |
| DIMETAPP COUGH & COLD COLOUR FREE oral liquid bottle | 60796 | Medicine | A | 7/25/1997 | |
| PHARMACY CHOICE COUGH & COLD ELIXIR PE oral liquid bottle | 132943 | Medicine | A | 11/14/2006 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DM COUGH AND COLD SYRUP | 02266466 | Syrup - Oral | 2 MG / 5 ML | 12/18/2006 | |
| DM COUGH AND COLD LIQUID | tanta pharmaceuticals inc | 02267446 | Solution - Oral | 2.0 MG / 5 ML | 2/20/2007 |
| DIMETAPP COUGH & COLD LIQUI-GELS - CAP | whitehall-robins inc. | 02215314 | Capsule - Oral | 4 MG | 10/22/1996 |
| EXTRA STRENGTH COLD SYRUP | 02266199 | Syrup - Oral | 4 MG / 5 ML | 12/18/2006 | |
| COLD LIQUID | tanta pharmaceuticals inc | 02267411 | Solution - Oral | 2 MG / 5 ML | 2/20/2007 |
| DECONGESTANT ANTIHISTAMINIC SYRUP | 00576689 | Elixir - Oral | 4 MG / 5 ML | 12/31/1984 | |
| DIMETAPP | foundation consumer brands, llc | 02243980 | Syrup - Oral | 2 MG / 5 ML | 7/23/2001 |
| EXTRA STRENGTH DM COUGH AND COLD LIQUID | tanta pharmaceuticals inc | 02267454 | Solution - Oral | 4.0 MG / 5 ML | 2/5/2007 |
| DIMETAPP ORAL INFANT COLD DROPS | wyeth consumer healthcare inc. | 02243945 | Liquid - Oral | 0.5 MG / ML | 8/6/2001 |
| DIMEGAN INJ 10MG/ML | dexo sa labs pharms | 00584533 | Liquid - Subcutaneous
,
Intramuscular | 10 MG / ML | 12/31/1988 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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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