ALA-HIST IR

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: ALA-HIST IR
Generic name: DEXBROMPHENIRAMINE MALEATE
Manufacturer: Poly Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 0d203b5c-8b10-428b-8703-17be6b4ce6eb
SPL ID: 4513db4f-e8f2-ecc6-e063-6294a90a1b17
Version: 11
Effective date: 2025-12-03
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:37

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		ALA-HIST IR	openfda.brand_name
generic name		DEXBROMPHENIRAMINE MALEATE	openfda.generic_name
manufacturer name		Poly Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	50991-783-60	openfda.package_ndc
ndc	package	50991-783-02	openfda.package_ndc
ndc	product	50991-783	openfda.product_ndc
ndc11	package	50991078360	derived:openfda.package_ndc
ndc11	package	50991078302	derived:openfda.package_ndc
rxcui		2262295	openfda.rxcui
rxcui		2262293	openfda.rxcui
spl id		4513db4f-e8f2-ecc6-e063-6294a90a1b17	id
spl set id		0d203b5c-8b10-428b-8703-17be6b4ce6eb	set_id
unii		BPA9UT29BS	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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