Nasal Decongestant

Manufacturer
Product Quest Mfg.
Effective date
2018-03-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:02

Label at a glance#

ProductNasal Decongestant Rhinall
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure6 sections

Dosage and administration

Adults and children 12 years of age and over: 2 or 3 drops in each nostril not more often than every 4 hours. Children under 12 years of age : ask a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active ingredient                     Purpose

Phenylephrine HCl 0.25%........Nasal decongestan

INDICATIONS & USAGE SECTION

Uses


Temporarly relieves nasal congestion due to • common cold • hay fever or other respiratory allergies associated with sinusitis • stuffy nose
Helps clear nasal passages; shrinks swollen membranes.
Temporarily restores freer breathing through the nose.
Helps decongest sinus openings and passages; temporarily relieves sinus congestion.

Warnings

WARNINGS SECTION

Do not exceed recommended dosage


Ask a doctor before use if you have: • heart disease • high blood pressure • diabetes• thyroid disease • difficulty in urination due to enlargement of the prostate gland

When using this product temporary discomfort may occur such as: • burning • stinging • sneezing • increase in nasal discharge • Use by more than one person may spread infection


Stop use and ask doctor if symptoms persist.

Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
If pregnant or breastfeeding, ask a health care professional before use.

KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: 2 or 3 drops in each nostril not more often than every 4 hours. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients


Benzalkonium Chloride, Chlorobutanol Hemihydrate, Disodium EDTA, Polysorbate, Sodium Bisulfite, Sodium Chloride, Sorbitol, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234576phenylephrine HCl 0.25 % Nasal SprayPSN2
1234576phenylephrine hydrochloride 2.5 MG/ML Nasal SpraySCD2
1234576phenylephrine hydrochloride 0.25 % Nasal SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64048-5000-12020-01-31C16284748780-19d75b9cf-ce7b-f424-e053-dadaa90a57ceFrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64048-5000-1Nasal DecongestantRhinall1 in 1 CARTONSPRAY12
64048-5000-1Nasal DecongestantRhinall40 mL in 1 TUBESPRAY402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64048-5000NASAL DECONGESTANT RHINALL (PHENYLEPHRINE HYDROCHLORIDE 0.25) SPRAY [PRODUCT QUEST MFG.]2Legacy NDC, 2 package rows20180329_16c1b9f4-23da-43d2-a7b6-b0851370b4bb.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64048-500064048-5000-1

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
6ab3071a-e8ba-46b0-aec2-16ef059406de16c1b9f4-23da-43d2-a7b6-b0851370b4bb2018-03-29WarningsExact identifier
spl id: 6ab3071a-e8ba-46b0-aec2-16ef059406de
spl set id: 16c1b9f4-23da-43d2-a7b6-b0851370b4bb

Reported adverse events (FAERS/openFDA)#

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