FDA.reportPublic FDA data

ALA-HIST IR 2 mg Tablets

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:20:34

Label at a glance#

ProductALA-HIST IR
Active ingredientDEXBROMPHENIRAMINE MALEATE
Label structure8 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

Dosage and administration

Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age:  1/2 tablet every 4 to 6  hours, not to exceed 3 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. Contains color additives including FD&C Yellow No. 5 (tartrazine). Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

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

Warnings

WARNINGS 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 to 6
hours, not to exceed
6 tablets in 24 hours.
Children 6 to under
12 years of age:  		1/2 tablet every 4 to 6 
hours, not to exceed
3 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.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355

Rev. 02/12

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-783-60



ALA-HIST IR

2 mg Tablets

Antihistamine

Each tablet contains:

Dexbrompheniramine Maleate.........2 mg

60 Tablets

Usual Dosage: See product foldout for full

prescribing information

Tamper evident by foil seal under cap. Do not

use if foil seal is broken or missing.

KEEP THIS AND ALL DRUGS OUT OF

REACH OF CHILDREN.

Store at controlled room temperature 15°-30°C

(59°-86°F).

Manufactured for:

Poly Pharmaceuticals

Rev. 02/12

labellabel

insertinsert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2262295ALA-HIST IR 2 MG Oral TabletPSN11
2262293dexbrompheniramine maleate 2 MG Oral TabletPSN11
2262295dexbrompheniramine maleate 2 MG Oral Tablet [Ala-Hist IR]SBD11
2262293dexbrompheniramine maleate 2 MG Oral TabletSCD11
2262295Ala-Hist IR (dexbrompheniramine maleate 2 MG) Oral TabletSY11
2262295Ala-Hist IR 2 MG Oral TabletSY11
2262295AlaHist IR 2 MG Oral TabletSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350991783605GTIN-13: 0350991783605
EAN-13: 0350991783605
GTIN-12: 350991783605
UPC-A: 350991783605
GTIN storage (14 digits): 00350991783605		alahistIR.jpg, alahisIR2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-783-02ALA-HIST IR1 in 1 BLISTER PACKTABLET111
50991-783-02ALA-HIST IR12 in 1 CARTONTABLET1211
50991-783-60ALA-HIST IR60 in 1 BOTTLE, PLASTICTABLET6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-783-60EA - Each50991-7839c42708d-fac3-4149-b21e-c6e82426a3d412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BS4
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RP4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH484
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-78350991-783-02, 50991-783-60

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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
ALA-HIST IRDEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.0d203b5c-8b10-428b-8703-17be6b4ce6eb2025-12-03WarningsExact identifier
ndc (package): 50991-783-60
ndc (package): 50991-783-02
ndc (product): 50991-783
ndc11 (package): 50991078360
ndc11 (package): 50991078302
spl id: 4513db4f-e8f2-ecc6-e063-6294a90a1b17
spl set id: 0d203b5c-8b10-428b-8703-17be6b4ce6eb

Reported adverse events (FAERS/openFDA)#

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