Overview
Bromotheophylline is the active moiety of pamabrom, a mixture of 2-amino-2-methyl-propanol and bromotheophylline. From this mixture, bromotheophylline acts as a weak diuretic that has been used along with some analgesics to relieve the symptoms of premenstrual syndrome. Bromotheophylline is categorized on the FDA as a drug substance with an inactive state since March, 1980. It is also approved by Health Canada to be used alone or in combination with Acetaminophen in OTC products.
Indication
Bromotheophylline is used as a diuretic and also, in combination with Acetaminophen, it is used for the relief of temporary water weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual periods.
Associated Conditions
- Premenstrual Syndrome (PMS)
- Menstrual syndrome
- Water retention
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Unifirst First Aid Corporation | 47682-723 | ORAL | 25 mg in 1 1 | 9/9/2025 | |
| Unifirst First Aid Corporation | 47682-823 | ORAL | 25 mg in 1 1 | 9/9/2025 | |
| L.N.K. International, Inc. | 50844-679 | ORAL | 25 mg in 1 1 | 8/20/2025 | |
| Kobayashi Healthcare International, Inc. | 52389-349 | ORAL | 50 mg in 1 1 | 5/7/2025 |
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 |
|---|---|---|---|---|---|
| PANADOL MENSTRUAL CAPLET | STERLING DRUG (M) SDN BHD | SIN11051P | TABLET, FILM COATED | 25 mg | 7/28/1999 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| RELIEVOL PMS REGULAR STRENGTH TABLETS | tanta pharmaceuticals inc | 02240159 | Tablet - Oral | 25 MG | N/A |
| PAMPRIN PMS CAPLETS | sanofi consumer health inc | 02240359 | Tablet - Oral | 25 MG | 3/24/2001 |
| PAMPRIN TAB | chattem canada | 00599174 | Tablet - Oral | 25 MG | 12/31/1984 |
| TRENDAR PMS TABLETS | whitehall-robins inc. | 01931105 | Tablet - Oral | 25 MG | 12/31/1976 |
| PAMPRIN EXTRA STRENGTH CAPLETS | sanofi consumer health inc | 00718130 | Tablet - Oral | 25 MG | 12/31/1986 |
| MIDOL PMS | Bayer Inc | 02247729 | Tablet - Oral | 25 MG | N/A |
| EXTRA STRENGTH TYLENOL MENSTRUAL CAPLETS | mcneil consumer healthcare division of johnson & johnson inc | 02231239 | Tablet - Oral | 25 MG | 1/27/1999 |
| MIDOL BLOAT RELIEF | Bayer Inc | 02527324 | Tablet - Oral | 50 MG | N/A |
| MIDOL EXTRA STRENGTH PMS | bayer inc consumer care | 02150506 | Tablet - Oral | 25 MG | 12/31/1995 |
| DIUREX WATER CAPLETS | alva-amco pharmacal companies, llc | 02242893 | Tablet - Oral | 50 MG | 3/12/2001 |
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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