Overview
A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than promethazine.
Background
A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than promethazine.
Indication
For the treatment of rhinitis, urticaria, allergy, common cold, asthma and hay fever.
Associated Conditions
- Allergic Conjunctivitis (AC)
- Allergic Contact Dermatitis
- Allergic Reaction
- Allergic Rhinitis (AR)
- Allergic cough
- Allergies caused by Serum
- Allergy to Tree Pollen
- Allergy to vaccine
- Angioneurotic Edema
- Asthma
- Bronchial Asthma
- Bronchitis
- Common Cold
- Conjunctival congestion
- Conjunctivitis
- Cough
- Cough caused by Common Cold
- Coughing caused by Flu caused by Influenza
- Drug Allergy
- Epiphora
- Eye allergy
- Fever
- Flu caused by Influenza
- Food Allergy
- Headache
- Headache caused by Allergies
- House Dust Mite Allergy
- Itching of the nose
- Itching of the throat
- Migraine
- Nasal Congestion
- Nasal Congestion caused by Common Cold
- Productive cough
- Pruritus
- Rash
- Rhinorrhoea
- Seasonal Allergic Conjunctivitis
- Sinus Congestion
- Sinusitis
- Sneezing
- Transfusion Reactions
- Upper Respiratory Tract Infection
- Upper respiratory tract congestion
- Upper respiratory tract hypersensitivity reaction, site unspecified
- Urticaria
- Vasomotor Rhinitis
- Acute Rhinitis
- Allergic purpura
- Conjunctival hyperemia
- Dry cough
- Excess mucus or phlegm
- Itchy throat
- Mild bacterial upper respiratory tract infections
- Ocular hyperemia
- Throat inflammation
- Upper respiratory symptoms
- Watery itchy eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/30 | Phase 2 | Recruiting | |||
2019/05/07 | Not Applicable | UNKNOWN | |||
2019/03/19 | Phase 3 | Completed | |||
2019/01/15 | Not Applicable | Completed | |||
2018/07/11 | Phase 4 | Completed | |||
2017/11/06 | Phase 2 | Terminated | |||
2016/03/29 | Phase 2 | Terminated | |||
2014/02/19 | Phase 2 | Terminated | |||
2010/09/27 | Not Applicable | Completed | |||
2009/03/02 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Tris Pharma Inc | 27808-086 | ORAL | 8 mg in 5 mL | 5/31/2021 | |
| Haleon US Holdings LLC | 0573-0196 | ORAL | 4 mg in 1 1 | 4/9/2025 | |
| DLC Laboratories, Inc. | 24286-1551 | ORAL | 1 mg in 5 mL | 5/15/2025 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0087 | ORAL | 8 mg in 5 mL | 1/10/2023 | |
| Physicians Total Care, Inc. | 54868-5957 | ORAL | 8 mg in 1 1 | 6/8/2012 | |
| Haleon US Holdings LLC | 0573-2161 | ORAL | 4 mg in 1 1 | 4/9/2025 | |
| Strategic Sourcing Services LLC | 70677-1016 | ORAL | 4 mg in 1 1 | 4/9/2025 | |
| Rebel Distributors Corp | 21695-900 | ORAL | 4 mg in 5 mL | 1/26/2011 | |
| Atlantic Biologicals Corps | 17856-0235 | ORAL | 8 mg in 5 mL | 10/17/2014 | |
| Atley Pharmaceuticals, Inc. | 59702-800 | ORAL | 4 mg in 5 mL | 2/22/2010 |
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 |
|---|---|---|---|---|---|
| AXCEL CHLORPHENIRAMINE TABLETS 4 mg | SIN10511P | TABLET | 4 mg | 12/5/1998 | |
| ANTAMIN TABLET 4 mg | SIN02658P | TABLET | 4 mg | 4/27/1989 | |
| ALLERSIN-F TABLET 4 mg | SIN03180P | TABLET | 4 mg | 6/2/1989 | |
| NAZAL SPRAY | SIN03722P | SPRAY | 500 mg/100 ml | 11/6/1989 | |
| CHLORPHENIRAMINE TABLET 4 mg | SIN02533P | TABLET | 4 mg | 4/18/1989 | |
| CHLORAMINE TABLET 4 mg | SIN02632P | TABLET | 4 mg | 4/21/1989 | |
| CHLORSEDYL LINCTUS | SIN02933P | ELIXIR | 4 mg/5 ml | 5/22/1989 | |
| CHLORPYRIMINE TABLET 4 mg | ATLANTIC LABORATORIES CORPN LTD | SIN03442P | TABLET | 4 mg | 6/16/1989 |
| ANTAMIN SYRUP 4 mg/5 ml | SIN05030P | SYRUP | 4 mg/5 ml | 8/30/1990 | |
| CHLORMINE SYRUP 4 mg/5 ml | SIN02527P | SYRUP | 4 mg/5ml | 4/18/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Chlorphenamine Maleate Injection | 国药准字H35020362 | 化学药品 | 注射剂 | 10/24/2019 | |
| Chlorphenamine Maleate Injection | 国药准字H35020087 | 化学药品 | 注射剂 | 2/28/2020 | |
| Chlorphenamine Maleate Injection | 国药准字H41022116 | 化学药品 | 注射剂 | 4/1/2020 | |
| Chlorphenamine Maleate Injection | 国药准字H32020042 | 化学药品 | 注射剂 | 9/2/2020 | |
| Chlorphenamine Maleate Injection | 国药准字H36021218 | 化学药品 | 注射剂 | 7/16/2022 | |
| Chlorphenamine Maleate Injection | 国药准字H32026616 | 化学药品 | 注射剂 | 9/9/2020 | |
| Chlorphenamine Maleate Injection | 国药准字H51023260 | 化学药品 | 注射剂(注射液) | 1/8/2021 | |
| Chlorphenamine Maleate Injection | 国药准字H42021032 | 化学药品 | 注射剂 | 6/16/2022 | |
| Chlorphenamine Maleate Injection | 国药准字H37021945 | 化学药品 | 注射剂 | 2/28/2020 | |
| Chlorphenamine Maleate Injection | 国药准字H32021722 | 化学药品 | 注射剂 | 8/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FAST FLU TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 10/18/2002 |
| SURE-RELIEF COLD AND COUGH CAP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 6/30/2000 |
| PFC COUGH SYRUP CM FORMULA | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 7/9/2010 |
| THURAMIN COUGH SYRUP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 7/28/2001 |
| CHLORPHENIRAMINE SYR.4MG/5ML | N/A | neochem pharmaceutical laboratories ltd. | N/A | N/A | 1/2/1992 |
| CHLORPHENIRAMINE SYRUP 8MG/5ML | N/A | neochem pharmaceutical laboratories ltd. | N/A | N/A | 1/2/1992 |
| UNI-CODPLEX SYRUP | N/A | N/A | N/A | 12/14/1998 | |
| NEW-PRITMIN TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 7/9/2010 |
| RHINO-COMFORT TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 11/21/2001 |
| X-COLD CAP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 6/30/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AVALLON COLD & FLU DAY + NIGHT RELIEF PE tablet blister pack | 300169 | Medicine | A | 3/1/2018 | |
| CHEMISTS' OWN CHILDREN'S COLD AND ALLERGY RELIEF LIQUID 6 YEARS TO ADULT oral liquid bottle | 71041 | Medicine | A | 9/14/1999 | |
| TRUST FOR KIDS DECONGESTANT & ANTIHISTAMINE ELIXIR oral liquid - solution bottle | 214691 | Medicine | A | 9/17/2013 | |
| DEMAZIN KIDS 6+ COLD RELIEF BLUE SYRUP bottle | 18813 | Medicine | A | 10/8/1991 | |
| APOHEALTH COLD RELIEF paracetamol 500 mg and chlorphenamine maleate 2 mg tablet blister pack | 254172 | Medicine | A | 8/11/2015 | |
| APOHEALTH COLD & FLU RELIEF DAY/NIGHT uncoated tablet blister pack | 236266 | Medicine | A | 4/16/2015 | |
| DEMAZIN ORIGINAL COLD + FLU RELIEF DAY + NIGHT tablet blister pack | 286002 | Medicine | A | 2/22/2017 | |
| BLOOMS THE CHEMIST PE DAY + NIGHT COLD & FLU RELIEF tablet blister pack | 294345 | Medicine | A | 9/26/2017 | |
| SUDAFED PE NIGHT tablet blister pack | 123048 | Medicine | A | 10/25/2005 | |
| LOGICIN HAY FEVER tablet blister pack | 54165 | Medicine | A | 12/12/1995 |