FDA.reportPublic FDA data

Aprodine

Manufacturer
Proficient Rx LP
Effective date
2019-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:05:54

Label at a glance#

ProductAprodine
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold 

Dosage and administration

• adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. • children under 12 years: do not use this product in children under 12 years of age 

Storage and handling

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 60 mg
Triprolidine HCl 2.5 mg 

Purpose

OTC - PURPOSE SECTION

Nasal decongestant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold 

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years: do not use this product in children under 12 years of age 

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica gel, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 71205-100-24

Aprodine™
TABLETS

TRIPROLIDINE HCl AND PSEUDOEPHEDRINE HCl
DECONGESTANT/ANTIHISTAMINE/FILM COATED

Head Cold & Allergy Medicine

Relieves:
• Nasal Congestion • Runny Nose
• Sneezing • Itchy, Watery Eyes

24 TABLETS

TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

50844                 REV0612M17808
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA           M-17

Relabeled by
Proficient Rx LP
Thousand Oaks, CA 91320
Re-Order No. 700796
Rev. 09/13

71205-100-24
71205-100-24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-100-24EA - Each71205-1009fca038b-9abc-4f75-bff7-c36527496f9012018-10-11
0904-0250-24EA - Each0904-0250d0772455-977b-47b4-9366-6cc86a80868112012-07-24
0904-0250-59EA - Each0904-0250ceeebd36-eae4-44ff-af24-2f53364e174912012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71205-10071205-100-24
0904-0250

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cfd75f6f-1fa4-430d-b478-7aaca348f152dbd8e15e-7bb0-46b5-9d69-3f8ffaf3bfda2024-10-01WarningsExact identifier
spl set id: dbd8e15e-7bb0-46b5-9d69-3f8ffaf3bfda

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.