FDA.reportPublic FDA data

Durahist

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:07

Label at a glance#

ProductDurahist
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours, not to exceed 4 tablets in 24 hours. Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 2 tablets in 24 hours. Children under 6 years of age: Consult a doctor.

Storage and handling

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Durahist Tablets are pink caplet shaped, scored tablets, debossed "Poly" bisect "865" on one side and plain on the other.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose
Dexbrompheniramine Maleate .................. Antihistamine
Pseudoephedrine HCI ................... Nasal Decongestant

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2mg
Pseudoephedrine HCI 60mg

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

WARNINGS SECTION

Do not exceed recommended dosage.

OTC - DO NOT USE SECTION

Do not use this product 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children
12 years of age and
over: 		1 tablet every 4 to 6
hours, not to exceed
4 tablets in 24 hours.
Children 6 to under
12 years of age: 		1/2 tablet every 4 to 6
hours, not to exceed
2 tablets in 24 hours.
Children under 6
years of age: 		Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 15° - 30°C (59° - 86°F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Durahist Tablets are pink caplet shaped, scored tablets, debossed "Poly" bisect "865" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lake Blend Red, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355

Rev. 09/2024

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The packaging below represents the labeling currently used.

Principal display panel for 90 tablets label:

NDC 50991-865-90

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN3
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350991865905GTIN-13: 0350991865905
EAN-13: 0350991865905
GTIN-12: 350991865905
UPC-A: 350991865905
GTIN storage (14 digits): 00350991865905		Durahist865.jpg

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
50991-865-02Durahist12 in 1 BLISTER PACKTABLET123
50991-865-90Durahist90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-865-90EA - Each50991-8658791c7a2-1631-4d24-a90c-b348dd0e3db812025-06-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-86550991-865-90, 50991-865-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MAGNESIUM STEARATE70097M6I30IACT
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
ndc (package): 50991-865-90
ndc (package): 50991-865-02
ndc (product): 50991-865
ndc11 (package): 50991086502
ndc11 (package): 50991086590
spl id: 472deea6-1315-b265-e063-6394a90a0e34
spl set id: 33d71863-5cac-669f-e063-6394a90a6f21

Reported adverse events (FAERS/openFDA)#

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