Meds A-Z
Phenylpropanolamine Hydrochloride
Detailed information about Phenylpropanolamine Hydrochloride
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
What it does:
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
When it's needed:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
Call your vet sooner if you notice:
- Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Phenylpropanolamine Hydrochloride
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Pegasus Laboratories, Inc.
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200787 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141517 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (32)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055768
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 6 • Secondary summaries: 0
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15526 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/15784/Phenylpropanolamine%20Hydrochloride · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/6907 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/6949/PROIN%20ER%E2%84%A2 · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/881 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2214/PROIN%C2%AE%20Chewable%20Tablets · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
At a Glance
Quick facts and links to official labeling and safety signals.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:04 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Diagnosis-code mappings are not available for this medication yet.
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 49427-141-48 | 49427 | - | |
| 49427-141-50 | 49427 | - | |
| 49427-315-48 | 49427 | - | |
| 49427-315-50 | 49427 | - | |
| 49427-316-48 | 49427 | - | |
| 49427-316-50 | 49427 | - | |
| 49427-344-44 | 49427 | - | |
| 49427-344-57 | 49427 | - | |
| 49427-345-44 | 49427 | - | |
| 49427-345-57 | 49427 | - | |
| 49427-346-44 | 49427 | - | |
| 49427-346-57 | 49427 | - | |
| 49427-347-44 | 49427 | - | |
| 49427-347-57 | 49427 | - | |
| 86117-042-05 | 86117 | - | |
| 86117-042-09 | 86117 | - | |
| 86117-043-05 | 86117 | - | |
| 86117-043-09 | 86117 | - | |
| 86117-044-05 | 86117 | - | |
| 86117-044-09 | 86117 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-787 Approved June 11, 2024.pdf
• FOI summary • Official
• July 1, 2024
FDA FOI summary for application 200787
-
FOI Summary oN 141-517 Approved March 29, 2019.pdf
• FOI summary • Official
• April 1, 2019
FDA FOI summary for application 141517
-
UCM296349.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 141324
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only. (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Panting, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological')… (Official, 2026-02-12)
- usage: For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Phenylpropanolamine Hydrochloride
RX
Phenylpropanolamine hydrochloride
Chewable Tablets
• Oral
|
ZYVET AH, Inc. | ANADA 200-787 | Approved | Jul 1, 2024 |
|
PROIN ER™
RX
Phenylpropanolamine hydrochloride
Tablet
• Oral
|
Pegasus Laboratories, Inc. | NADA 141-517 | Approved | Apr 1, 2019 |
|
PROIN® Chewable Tablets
RX
Phenylpropanolamine hydrochloride
Scored Chewable Tablets
• Oral
|
Pegasus Laboratories, Inc. | NADA 141-324 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
What It's For (FDA Label Highlights)
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Composition / specifications
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
The total recommended dosage for oral administration is 2 mg/kg (0.91 mg/lb) of body weight twice daily. Phenylpropanolamine Hydrochloride is scored and dosage should be calculated in half-tablet increments.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
The recommended dosage is 2 to 4 mg/kg (0.9 to 1.8 mg/lb) of body weight once daily. Administer with food. Do not split or crush tablets. Dogs weighing less than 10 pounds cannot be safely dosed because tablet administration would result in a dose over 4 mg/kg.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs
- PROIN ER™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM296349.pdf
Summary
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
- PROIN® Chewable Tablets (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 0 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, ['Spitz - German Pomeranian', 'Chihuahua'], Male, 2 year, 4.536 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Eosinophilia, Monocytosis, Not urinating, Wrong drug dispensed, Pallor • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055766
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 2.00 Year
- Weight: 4.536 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 1 tablet per dose
- Frequency: 1 per day
Dog, Chihuahua, Male, 18 month, 4.99 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Not urinating, Pallor, Elevated alanine aminotransferase, Decreased cholesterol, Eosinophilia… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055768
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 18.00 Month
- Weight: 4.990 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 1 tablet per dose
- Frequency: 1 per day
Dog, Ridgeback - Rhodesian, Female, 11 year, 33.566 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Lack of efficacy - NOS, Drug dose administration interval too short, Overdose • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055767
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 11.00 Year
- Weight: 33.566 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet
- Dose: 1 tablet per dose
- Frequency: 1 per day
Dog, Catahoula Leopard Dog, Male, 2 year, 30 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per dose, Frequency: 1 per day • Reactions: Overdose, Underdose, Vomiting • Outcome: Outcome Unknown
- Report ID: CAN-USFDACVM-2025-CA-000084
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 2.00 Year
- Weight: 30.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Tablet, chewable
- Dose: 1 tablet per dose
- Frequency: 1 per day
Dog, Retriever - Labrador, Female, 4 year, 32.659 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Grand mal seizure • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-051860
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 4.00 Year
- Weight: 32.659 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Unassigned
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Share Your Thoughts
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.