FDA.reportPublic FDA data

Alahist D

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:27

Label at a glance#

ProductAlahist D
Active ingredientPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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, watery eyes  nasal congestion  reduces swelling of nasal passages

Dosage and administration

Directions Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age Children under 6 consult a doctor 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet) Purpose

Pheniramine Maleate 17mg​

Antihistamine
Phenylephrine HCl 10mgNasal 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, watery eyes
  •  nasal congestion 
    • reduces swelling of nasal passages

WARNINGS

WARNINGS SECTION

Do not exceed recommended dosage.

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.

Ask a doctor before use ifyou 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

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

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

Stop use and ask a doctor if
 nervousness, dizziness, or sleeplessness occur
 symptoms do not improve within 7 days or are accompanied by fever

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and over1 tablet every 4 hours, not to exceed 6 tablets in 24 hours

Children 6 to under 12 years of age

Children under 6 consult a doctor

1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients
Magnesium Stearate, Microcrystalline Cellulose, Natural Yellow, Sodium Starch Glycolate

QUESTIONS

OTC - QUESTIONS SECTION

Questions? Comments?
Call 1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Huntsville, AL 35763 Rev. 04/17

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information
Store at 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Alahist D Tablets are yellow,debossed "A" bisect "D" on one side and plain on the other.

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.

OTC - PURPOSE SECTION

Antihistamine

Nasal Decongestant

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

INSERTINSERT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286598ALAHIST D 17.5 MG / 10 MG Oral TabletPSN6
2286592pheniramine maleate 17.5 MG / phenylephrine HCl 10 MG Oral TabletPSN6
2286598pheniramine maleate 17.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet [Alahist D]SBD6
2286592pheniramine maleate 17.5 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD6
2286598Alahist D (pheniramine maleate 17.5 MG / phenylephrine HCl 10 MG) Oral TabletSY6

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
50991-776-01Alahist D100 in 1 BOTTLETABLET1006
50991-776-02Alahist D12 in 1 BLISTER PACKTABLET126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-776-01EA - Each50991-7762f258a05-0c23-4d37-a5bf-609742e985d412020-05-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-77650991-776-01, 50991-776-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENIRAMINE MALEATENYW905655BACTIB
MAGNESIUM STEARATE70097M6I30IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

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 DPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPoly Pharmaceuticals, Inc.a1b8533a-ef8b-57cc-e053-2995a90a5d9e2025-12-03WarningsExact identifier
ndc (package): 50991-776-02
ndc (package): 50991-776-01
ndc (product): 50991-776
ndc11 (package): 50991077602
ndc11 (package): 50991077601
spl id: 4513de1e-86ae-0275-e063-6294a90a2c6a
spl set id: a1b8533a-ef8b-57cc-e053-2995a90a5d9e

Reported adverse events (FAERS/openFDA)#

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