Meds A-Z

Phenylpropanolamine

Detailed information about Phenylpropanolamine

Official label facts Owner quick guide first Marketing clearly labeled

Talk to a Vet / Find a Vet Near You Start Symptom Intake

Showing simplified owner view. Switch to Vet View for full technical detail.

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?

Talk to a Vet / Find a Vet Near You

Image coming soon

Phenylpropanolamine

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.

Species: Both

Manufacturer: Pegasus Laboratories, Inc.

Form: Chewable Tablets, Scored Chewable Tablets, Tablet

Identifiers:

ANADA: 200787 NADA: 141324 NADA: 141517 NDC Package: 49427-141-48 NDC Package: 49427-141-50 NDC Package: 49427-315-48 NDC Package: 49427-315-50 NDC Package: 49427-316-48 NDC Package: 49427-316-50 NDC Package: 49427-344-44 NDC Package: 49427-344-57 NDC Package: 49427-345-44 NDC Package: 49427-345-57 NDC Package: 49427-346-44 NDC Package: 49427-346-57 NDC Package: 49427-347-44 NDC Package: 49427-347-57 NDC Package: 86117-042-05 NDC Package: 86117-042-09 NDC Package: 86117-043-05

Source metadata:

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.

Source metadata:

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.

Tracked signals

Reported cases

Serious reports

Species represented

Most Reported Reactions

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

Species	Seriousness	Frequency	Reports
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Non-serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Non-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	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Non-serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Non-serious	-	1
Dog	Serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-054385

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 6 • Secondary summaries: 0

Official label facts

FOI Summary oA 200-787 Approved June 11, 2024.pdf · FOI
Phenylpropanolamine Hydrochloride · SPL
FOI Summary oN 141-517 Approved March 29, 2019.pdf · FOI
PROIN ER™ · SPL
UCM296349.pdf · FOI
PROIN® Chewable Tablets · SPL

Secondary summaries

No source yet.

Source metadata:

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.

Source metadata: No source yet.

Talk to a Vet / Find a Vet Near You

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.

Data freshness

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

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: PROIN ER™ PROIN® Chewable Tablets Phenylpropanolamine Hydrochloride

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Dog

Rx/OTC: RX

Form/route: Chewable Tablets, Scored Chewable Tablets, Tablet • Oral

Applications: ANADA 200-787 • NADA 141-517 • NADA 141-324

Documents: 3 (FOI: 3) • SPL: 3 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 56 • Cat 0 • View

Case summaries: 5 (showing 5) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Urinary incontinence (spay incontinence, neurogenic)

Linked using: Fda_Label (0.95)

Diagnosis Codes

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.

Owner-facing counseling points

Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only. (Contraindication, High)

Top reaction signals

Abdominal pain (1) Abnormal cytology (1) Abnormal radiograph finding (1) Anxiety (1) Bloody diarrhoea (1) Bone and joint disorder NOS (1) Crying (1) Death by euthanasia (1) Depression (1) Easily startled (1) Elevated amylase (1) Elevated blood urea nitrogen (BUN) (1) Elevated cholesterol (total) (1) Elevated creatinine (1) Elevated protein:creatinine ratio (1) Elevated symmetrical dimethylarginine (SDMA) (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers

Package NDC	Product NDC	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.

Official 6 Clinical 0 Manufacturer 0 Marketing 0

Current Field Facts

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): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Diarrhoea, Death by euthanasia, Elevated a… (Official, 2026-02-12)
usage: For the control of urinary incontinence due to urethral sphincter hypotonus in dogs. (Official, 2026-02-12)

Recent Revisions

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 Label highlights Official documents	ZYVET AH, Inc.	ANADA 200-787	Approved	Jul 1, 2024
PROIN ER™ RX Phenylpropanolamine hydrochloride Tablet • Oral Label highlights Official documents	Pegasus Laboratories, Inc.	NADA 141-517	Approved	Apr 1, 2019
PROIN® Chewable Tablets RX Phenylpropanolamine hydrochloride Scored Chewable Tablets • Oral Label highlights Official documents	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.

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

25, 50, or 75 mg phenylpropanolamine hydrochloride per tablet

Dogs

Indication

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

18, 38, 74, or 145 mg of phenylpropanolamine hydrochloride per tablet

Dogs

Indication

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each chewable tablet contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride.

Dogs

Indication

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

Dosage

The total recommended dosage for oral administration is 2 mg/kg (0.91 mg/lb) of body weight twice daily. The dosage should be calculated in half-tablet increments.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.For oral use in dogs only.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents

FOI FOI Summary oA 200-787 Approved June 11, 2024.pdf

Summary

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

SPL Packages

Phenylpropanolamine Hydrochloride (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI FOI Summary oN 141-517 Approved March 29, 2019.pdf

Summary

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs

SPL Packages

PROIN ER™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM296349.pdf

Summary

For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.

SPL Packages

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).

Dog

Digestive

Vomiting (83) Diarrhea (46) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1)

Neurologic

Tiredness (lethargy) (48)

Behavior

Anxiety (2) Anxiety (2) Anxiety (2) Anxiety (2) Anxiety (2) Anxiety (2)

Effectiveness

Lack of efficacy - NOS (25)

Other

Death by euthanasia (41) Elevated alanine aminotransferase (33) Urinary incontinence (30) Elevated blood urea nitrogen (26) Death by euthanasia (3) Death by euthanasia (3) Death by euthanasia (3) Death by euthanasia (3) Death by euthanasia (3) Death by euthanasia (3) Pain NOS (2) Pain NOS (2) Pain NOS (2) Pain NOS (2) Pain NOS (2) Pain NOS (2) Uncomfortable (2) Uncomfortable (2) Uncomfortable (2) Uncomfortable (2) Uncomfortable (2) Uncomfortable (2) Abdominal pain (1) Abdominal pain (1) Abdominal pain (1) Abdominal pain (1) Abdominal pain (1) Abdominal pain (1) Abnormal cytology (1) Abnormal cytology (1) Abnormal cytology (1) Abnormal cytology (1) Abnormal cytology (1) Abnormal cytology (1) Abnormal radiograph finding (1) Abnormal radiograph finding (1) Abnormal radiograph finding (1) Abnormal radiograph finding (1) Abnormal radiograph finding (1) Abnormal radiograph finding (1)

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, Pinscher - Miniature, Female, 16 year, 4.1 kilogram • Drug: MSK, Oral • Reactions: Whining, Not sleeping, Anxiety, Easily startled • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-055484
Serious AE: No
Treated For AE: No
Sex: Female
Age: 16.00 Year
Weight: 4.100 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral

Reactions Reported:

Whining Not sleeping Anxiety Easily startled

Outcomes: Outcome Unknown

Dog, Beagle, Female, 16 year, 15.694 kilogram • Drug: MSK, Unassigned, Oral, Dose: 25 Milligram per animal, Frequency: 12 per hour • Reactions: Bloody diarrhoea, Tiredness (lethargy), Crying, Elevated symmetrical dimethylarginine, Urine abnormalities NOS… • Outcome: Euthanized

Report ID: USA-USFDACVM-2025-US-053393
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 16.00 Year
Weight: 15.694 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Unassigned
Dose: 25 Milligram per animal
Frequency: 12 per hour

Reactions Reported:

Bloody diarrhoea Tiredness (lethargy) Crying Elevated symmetrical dimethylarginine Urine abnormalities NOS Hyperkalaemia Low sodium-potassium ratio Elevated cholesterol Elevated protein:creatinine ratio Proteinuria Death by euthanasia

Outcomes: Euthanized

Dog, Terrier - Rat, Female, 15 year, 7.711 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Straining to defecate, Pain NOS, Not eating, Abdominal pain… • Outcome: Euthanized

Report ID: USA-USFDACVM-2025-US-054385
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 15.00 Year
Weight: 7.711 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Vomiting Straining to defecate Pain NOS Not eating Abdominal pain Uncomfortable Depression Elevated amylase Elevated blood urea nitrogen Elevated creatinine Abnormal radiograph finding Enlarged liver Tracheal collapse Pancreatitis NOS Fluid in abdomen NOS Gall bladder & bile duct disorder NOS Gall bladder mucocele Death by euthanasia

Outcomes: Euthanized

Dog, ['Shepherd Dog - German', 'Dog (unknown)'], Female, 10 year, 26.308 kilogram • Drug: MSK, Tablet, Oral • Reactions: Weight loss, Urine leakage, Spleen nodules, Abnormal cytology, Uncomfortable… • Outcome: Euthanized

Report ID: USA-USFDACVM-2025-US-051892
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 10.00 Year
Weight: 26.308 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Oral
Form: Tablet

Reactions Reported:

Weight loss Urine leakage Spleen nodules Abnormal cytology Uncomfortable Fracture Bone and joint disorder NOS Death by euthanasia Anxiety Osteosarcoma Pain NOS Limb non-weight bearing

Outcomes: Euthanized

Dog, Shepherd Dog - German, Female, 13 year, 33.566 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Partial lack of efficacy • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-049083
Serious AE: No
Treated For AE: No
Sex: Female
Age: 13.00 Year
Weight: 33.566 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Partial lack of efficacy

Outcomes: Ongoing

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.

No community reviews yet. Be the first to share your experience.

This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on PetWisePlus are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Phenylpropanolamine

Pet Owner Quick Guide