Meds A-Z

Phenylpropanolamine

Detailed information about Phenylpropanolamine

Official label facts Owner quick guide first Marketing clearly labeled

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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
PROIN® Chewable Tablets · official_label
openFDA case USA-USFDACVM-2025-US-054385 · adverse_reaction

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

very low energy (1 reports)
Proteinuria (1 reports)
Pancreatitis NOS (1 reports)

When to call the vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.
Facial swelling or hives.
Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

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?

Safety & side effects

What to watch:

very low energy
Proteinuria
Pancreatitis NOS

Most reported reactions:

Tiredness (lethargy) (1 reports)
Proteinuria (1 reports)
Pancreatitis NOS (1 reports)

When to call your vet:

Repeated vomiting or diarrhea.
Severe lethargy (hard to wake, very low energy).
Collapse or fainting.
Trouble breathing.

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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness

Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Mar 9, 2026, 10:05 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

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

Grouped by Body System

Digestive (1) · Bloody diarrhoea Neurologic (2) · Tiredness (lethargy), Depression Behavior (1) · Anxiety Effectiveness (1) · Partial lack of efficacy Other (27) · Proteinuria, Pancreatitis NOS, Pain NOS

Most Reported Reactions

Body system	Cases	Species	Serious cases
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
Other	1	Dog	1

Species coverage: Dog (32)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Neurologic	Dog	Serious	-	1
Other	Dog	Serious	-	1
Effectiveness	Dog	Non-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	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	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Non-serious	-	1
Neurologic	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Digestive	Dog	Serious	-	1
Behavior	Dog	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1

Source metadata:

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)

No owner handouts linked yet.

Official label / PI (0)

No official label or package insert links yet.

SPL (3)

Phenylpropanolamine Hydrochloride · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/15784/Phenylpropanolamine%20Hydrochloride
PROIN ER™ · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/6949/PROIN%20ER%E2%84%A2
PROIN® Chewable Tablets · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2214/PROIN%C2%AE%20Chewable%20Tablets

FOI (3)

FOI Summary oA 200-787 Approved June 11, 2024.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/15526
FOI Summary oN 141-517 Approved March 29, 2019.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/6907
UCM296349.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/881

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

Veterinary reference (advanced)

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 Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
openFDA reaction terms: Source FDA openFDA | Refreshed Mar 9, 2026, 10:05 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 21 • 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

Tiredness (lethargy) (1) Proteinuria (1) Pancreatitis NOS (1) Pain NOS (1) Osteosarcoma (1) Not eating (1) Low sodium-potassium ratio (1) Limb non-weight bearing (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 & Change Log

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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive

Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Neurologic

Tiredness (1) • Dog Depression (1) • Dog

Showing top 5 for Neurologic.

Behavior

Anxiety (1) • Dog

Showing top 5 for Behavior.

Effectiveness

Partial lack of efficacy (1) • Dog

Showing top 5 for Effectiveness.

Other

Proteinuria (1) • Dog Pancreatitis NOS (1) • Dog Pain NOS (1) • Dog Osteosarcoma (1) • Dog Not sleeping (1) • Dog

Show more (22)

Not eating (1) • Dog Low sodium-potassium ratio (1) • Dog Limb non-weight bearing (1) • Dog Hyperkalaemia (1) • Dog Gall bladder mucocele (1) • Dog Gall bladder & bile duct disorder NOS (1) • Dog Fracture (1) • Dog Fluid in abdomen NOS (1) • Dog Enlarged liver (1) • Dog Elevated symmetrical dimethylarginine (1) • Dog Elevated protein:creatinine ratio (1) • Dog Elevated creatinine (1) • Dog Elevated cholesterol (1) • Dog Elevated blood urea nitrogen (1) • Dog Elevated amylase (1) • Dog Easily startled (1) • Dog Death by euthanasia (1) • Dog Crying (1) • Dog Bone and joint disorder NOS (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal cytology (1) • Dog Abdominal pain (1) • Dog

Showing top 5 for Other.

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.

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This medication has not been reviewed by a veterinarian yet.

Medical Disclaimer: The medication details provided on Roxee 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

Add to My Pet's Meds

Reviewed / Updated / Sources

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