FDA label 7635b023-c5c1-40ec-a4ec-d99e73411c17

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)

SPL set ID: 18836374-7e66-45bd-8380-3f9714de0b40
SPL ID: 7635b023-c5c1-40ec-a4ec-d99e73411c17
Version: 4
Effective date: 2014-11-04
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:00:56

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		7635b023-c5c1-40ec-a4ec-d99e73411c17	id
spl set id		18836374-7e66-45bd-8380-3f9714de0b40	set_id

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS For topical ophthalmic use only. Not for injection or oral use.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS In clinical studies lasting up to 17 weeks with ALAMAST ® ophthalmic solution, headache, rhinitis, and cold/flu symptoms were reported at an incidence of 10–25%. The occurrence of these side effects was generally mild. Some of these events were similar to the underlying ocular disease being studied. The following ocular and non-ocular adverse reactions were reported at an incidence of less than 5%: Ocular: burning, dry eye, foreign body sensation, and ocular discomfort. Non-Ocular: allergy, back pain, bronchitis, cough, dysmenorrhea, fever, sinusitis, and sneezing/nasal congestion.

Reported adverse events (FAERS/openFDA)#

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