FDA.reportPublic FDA data

NASAL and SINUS DECONGESTANT

Manufacturer
JHK Inc dba American Safety & First Aid
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:30

Label at a glance#

ProductNASAL and SINUS DECONGESTANT
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 12 years of age and older take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: ask a doctor

Storage and handling

do not use if packet is opened or torn store at room temperature, 59° - 86°F (15° - 30°C) avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Tablets)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

nasal decongestant

Use

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to:

  • common cold
  • hay fever or other upper respiratory allergies

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
  • Children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • do not use if packet is opened or torn
  • store at room temperature, 59° - 86°F (15° - 30°C)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C Red #27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 100 Tablet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product #1262

Nasal & Sinus
Decongestant II

Nasal Decongestant

Active ingredient:
Phenylephrine

  • Helps reduce nasal and sinus congestion and
    pressure, and helps restore free breathing
    through the nose

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

100 Tablets • 2 Tablets Per Packet

PRINCIPAL DISPLAY PANEL - 100 Tablet Box
PRINCIPAL DISPLAY PANEL - 100 Tablet Box

PRINCIPAL DISPLAY PANEL - 250 Tablet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product #1264

Nasal & Sinus
Decongestant II

Nasal Decongestant

Active ingredient:
Phenylephrine

  • Helps reduce nasal and sinus congestion and
    pressure, and helps restore free breathing
    through the nose

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2015 standards. They are sealed in
tamper-evident packets for safety and convenience.

250 Tablets • 2 Tablets Per Packet

PRINCIPAL DISPLAY PANEL - 250 Tablet Box
PRINCIPAL DISPLAY PANEL - 250 Tablet Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN2
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD2
1299145phenylephrine HCl 5 MG Oral TabletSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1262-12024-04-26C16284748780-11030e365-1138-111a-e063-dadaa90a10e2NASAL AND SINUS DECONGESTANT II
73598-1264-12024-04-26C16284748780-11030e365-1138-111a-e063-dadaa90a10e2NASAL AND SINUS DECONGESTANT II
73598-1262-12024-01-30C16284748780-11030e365-1138-111a-e063-dadaa90a10e2NASAL AND SINUS DECONGESTANT II
73598-1264-12024-01-30C16284748780-11030e365-1138-111a-e063-dadaa90a10e2NASAL AND SINUS DECONGESTANT II

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1262-1NASAL and SINUS DECONGESTANT2 in 1 PACKETTABLET22
73598-1262-1NASAL and SINUS DECONGESTANT50 in 1 BOXTABLET502
73598-1264-1NASAL and SINUS DECONGESTANT2 in 1 PACKETTABLET22
73598-1264-1NASAL and SINUS DECONGESTANT125 in 1 BOXTABLET1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1262NASAL AND SINUS DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240427_63e51305-2575-49c4-9fda-7b3e1b4b6ede.zip
73598-1264NASAL AND SINUS DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240427_63e51305-2575-49c4-9fda-7b3e1b4b6ede.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73598-126273598-1262-1
73598-126473598-1264-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

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
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
ndc (package): 73598-1264-1
ndc (package): 73598-1262-1
ndc (product): 73598-1262
ndc (product): 73598-1264
ndc11 (package): 73598126201
ndc11 (package): 73598126401
spl id: 050efff2-4886-4c50-a92c-3f216d200e8a
spl set id: 63e51305-2575-49c4-9fda-7b3e1b4b6ede

Reported adverse events (FAERS/openFDA)#

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