FDA.reportPublic FDA data

APRODINE

Manufacturer
A-S Medication Solutions
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:14

Label at a glance#

ProductAPRODINE
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed 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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 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 (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion

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
  • difficulty in urination due to enlargement of the 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 dosage
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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

  • do not take more than directed
  • 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

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-7085

NDC: 50090-7085-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Pseudoephedrine HCl, Triprolidine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099446pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral TabletPSN3
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7085-2APRODINE24 in 1 BLISTER PACKTABLET, FILM COATED243
50090-7085-2APRODINE1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7085APRODINE (PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240301_bbc268b8-fa66-4dc5-b935-f77ae39d28c8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7085-2EA - Each50090-7085aaaec6c4-b0b2-44f6-a5bc-f30ec33d9a3712024-03-12
0904-7302-24EA - Each0904-730211dcca6e-ea23-41da-a6e2-37516e80fdc012023-01-09
0904-7302-60EA - Each0904-7302cca0caf7-4be9-4c41-a80e-0f1c52bad1fc12023-01-09

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-708550090-7085-2
0904-7302

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
TRIPROLIDINE HYDROCHLORIDEYAN7R5L890ACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AprodinePSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLMajor Pharmaceuticals6612e514-2690-4f5b-8a82-0e54d362758f2025-11-19WarningsExact identifier
ndc (product): 0904-7302
APRODINEPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLA-S Medication Solutionsbbc268b8-fa66-4dc5-b935-f77ae39d28c82024-02-29WarningsExact identifier
ndc (package): 50090-7085-2
ndc (product): 50090-7085
ndc11 (package): 50090708502
spl id: 776706de-0208-42eb-8d93-5223b46440a9
spl set id: bbc268b8-fa66-4dc5-b935-f77ae39d28c8

Reported adverse events (FAERS/openFDA)#

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