Alahist PE

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:20:42

Label at a glance#

ProductAlahist PE
Active ingredientDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)
Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride 7.5 mg

Purpose

OTC - PURPOSE SECTION


Dexbrompheniramine Maleate- -Antihistamine
Phenylephrine Hydrochloride-- Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

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

Warnings

WARNINGS SECTION

Do not use this product

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

  • 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


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

When Using This product

OTC - WHEN USING SECTION

  • 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

Stop use and Ask Doctor if

OTC - STOP USE SECTION

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

If Pregnant or Breastfeeding

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 of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at 15°-30°C (59°-86°F). Supplied in a tight,light-resistant container with a child-resistant cap. Alahist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, D&C Red # 27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-800-882-1041

Alahist PE Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for

Poly Pharmaceuticals
Huntsville, AL 35763

labellabel

insertinsert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2391334dexbrompheniramine maleate 2 MG / phenylephrine HCl 7.5 MG Oral TabletPSN7
2391334dexbrompheniramine maleate 2 MG / phenylephrine hydrochloride 7.5 MG Oral TabletSCD7
2391334dexbrompheniramine maleate 2 MG / phenylephrine HCl 7.5 MG Oral TabletSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-788-02Alahist PE12 in 1 BLISTER PACKTABLET127
50991-788-90Alahist PE90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-788-90EA - Each50991-788913cc3c9-be68-4c88-97b3-8b8798f5788d12020-09-14

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-78850991-788-90, 50991-788-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
Alahist PEDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.ada2d582-5813-2029-e053-2a95a90ae5672025-12-03WarningsExact identifier
ndc (package): 50991-788-90
ndc (package): 50991-788-02
ndc (product): 50991-788
ndc11 (package): 50991078802
ndc11 (package): 50991078890
spl id: 4513e2ae-4504-8fd3-e063-6394a90a7ff0
spl set id: ada2d582-5813-2029-e053-2a95a90ae567

Reported adverse events (FAERS/openFDA)#

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