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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Both
Manufacturer: Multiple FDA sponsors
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. Species commonly shown: Both, Dog.
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Death by euthanasia, Elevated alanine aminotransferase (ALT), Urinary incontinence.
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Used for:
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Dosing note:
Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.
What to watch for:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Phenylpropanolamine; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 30 serious reports; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Vomiting (1 reports), Unsteady walking (ataxia) (1 reports), Falling (1 reports), Enlarged liver (1 reports), Elevated symmetrical dimethylarginine (1 reports)
Digestive (3), Neurologic (2), Behavior (3), Other (24)
Dog (32 reports)
Shepherd Dog - German (2), Retriever - Labrador (1), ['Terrier - Bull - American Pit', 'Dog (unknown)'] (1), Collie - Smooth-haired (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Phenylpropanolamine fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Vomiting, wobbly/unsteady walking, Falling
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 15, 2026, 10:04 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-03-23 · MSK · MSK
Received 2025-12-22 · MSK · MSK
Received 2025-12-10 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Neurologic | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (32)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Behavior | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
FOI · FOI
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
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 Animal Health, 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).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
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
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
FDA page: Open in Animal Drugs @ FDA
For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Source: FDA Animal Drugs @ FDA • Reference
Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Retriever - Labrador, Male, 19 month, 32.205 kilogram • Drug: MSK, Oral, Frequency: 1 per day • Reactions: Lack of efficacy (endoparasite) - tapeworm, Unclassifiable adverse event • Outcome: Outcome Unknown
Dog, ['Terrier - Bull - American Pit', 'Dog (unknown)'], Female, 13 year, 21.863 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Elevated creatinine, Inappropriate urination, Polyuria, Inappropriate defecation, Urinary incontinence… • Outcome: Ongoing
Dog, Collie - Smooth-haired, Female, 11 year, 30.9 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Generalised itching, Increased drinking, Polyuria • Outcome: Ongoing
Dog, Shepherd Dog - German, Female, 5 year, 38.918 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Swelling NOS, Lameness, Bone and joint disorder NOS, Abnormal radiograph finding • Outcome: Ongoing
Dog, Doberman Pinscher, Female, 9 year, 27.21 kilogram • Drug: MSK, Unknown • Reactions: Vomiting, UNPALATABLE • Outcome: Recovered/Normal
Dog, Shepherd Dog - German, Female, 11 year, 20.865 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Not eating, Tiredness (lethargy), Reluctant to move, Seizure NOS • Outcome: Ongoing
Dog, Bulldog - English, Female, 11.2 year, 29.94 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Urinary incontinence • Outcome: Ongoing
Dog, ['Shepherd Dog - German', 'Siberian Husky'], Female, 9 year, 34.019 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Difficulty going up/down stairs, Lying down, High leg gait • Outcome: Outcome Unknown
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.