FDA.reportPublic FDA data

Unishield Sinus Decongestant

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:02

Label at a glance#

ProductUnishield Sinus Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRug Factr

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

INDICATIONS & USAGE SECTION

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 1 tablet every 4 hours. Do not take more than 6 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? 800-480-5855

Unishield Sinus Decongestant Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unishield

Sinus Decongestant

Phenylephrine HCl 10 mg

100 Tablets/ 1 Tablet Per Packet

Pseudoephedrine Free Sinus Relief

Pull To Open

• For sinus headache, pain, pressure, and congestion

Compare active ingredients to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

208R208R

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN5
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-2083-3Unishield Sinus Decongestant100 in 1 BOXTABLET, FILM COATED1005
49314-2083-3Unishield Sinus Decongestant1 in 1 PACKETTABLET, FILM COATED15

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
49314-208349314-2083-3

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
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSES3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT

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
Unishield Sinus DecongestantPHENYLEPHRINE HCLUnishieldb8f68d9d-2d38-414a-e053-2a95a90a15ec2025-09-08WarningsExact identifier
ndc (package): 49314-2083-3
ndc (product): 49314-2083
ndc11 (package): 49314208303
spl id: 3e4c27ca-8364-a933-e063-6294a90a351a
spl set id: b8f68d9d-2d38-414a-e053-2a95a90a15ec

Reported adverse events (FAERS/openFDA)#

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