FDA.reportPublic FDA data

McKesson Phenylephrine HCl

Manufacturer
McKesson Medical-Surgical | Unifirst First Aid Corporation
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:20

Label at a glance#

ProductMcKesson Phenylephrine HCl
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenylephrine HCl 5mg

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves

  • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • sinus congestion and pressure

WARNINGS SECTION

Warnings

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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 dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4-6 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

Ask a doctor

OTHER SAFETY INFORMATION

Other information

  • store at room temperature 59º-86º F (15º-30º C).
  • tamper evident sealed packets.
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

McKesson

Phenylephrine Tablets

NDC 68599-1631-3

Phenylephrine HCl 5 mg

Pseudoephrine-free relief of nasal congestion due to the common cold.

2 Per Pack

250 Packs Per Box

MFR # 82479

205R205R

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN3
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD3
1299145phenylephrine HCl 5 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-1631-3McKesson Phenylephrine HCl250 in 1 BOXTABLET, FILM COATED2503
68599-1631-3McKesson Phenylephrine HCl2 in 1 PACKETTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-1631MCKESSON PHENYLEPHRINE HCL (PHENYLEPHRINE HCL) TABLET, FILM COATED [MCKESSON MEDICAL-SURGICAL]3Current NDC, Legacy NDC, 2 package rows20241109_e09060f7-ca0b-5f7c-e053-2995a90ab344.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-163168599-1631-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
McKesson Phenylephrine HClPHENYLEPHRINE HCLMcKesson Medical-Surgicale09060f7-ca0b-5f7c-e053-2995a90ab3442024-11-08WarningsExact identifier
ndc (package): 68599-1631-3
ndc (product): 68599-1631
ndc11 (package): 68599163103
spl id: 266bbe87-c019-f406-e063-6394a90a516c
spl set id: e09060f7-ca0b-5f7c-e053-2995a90ab344

Reported adverse events (FAERS/openFDA)#

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