Nasal and Sinus Decongestant

Manufacturer
Redicare LLC
Effective date
2021-07-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:12

Label at a glance#

ProductNasal and Sinus Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)........................................................ Purpose

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 5 mg.......................................................................................................Decongestant

Uses:

OTC - PURPOSE SECTION

Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing

Warnings:

WARNINGS SECTION

Do not use:

OTC - DO NOT USE SECTION

■ more than recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms do not improve ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland

If pregnant or breast-feeding a baby,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other Information:

INDICATIONS & USAGE SECTION

■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

corsscarmellose sodium, D&C Red #28, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DecongestantDecongestant

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 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
71105-333-682023-01-30C16284748780-1f386c649-bd4d-0266-e053-dadaa90a7c1aDecongestant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71105-333-68Nasal and Sinus Decongestant100 in 1 CARTONTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71105-333NASAL AND SINUS DECONGESTANT TABLET [REDICARE LLC]3Legacy NDC, 1 package rows20210703_47e0830f-31e4-5ff0-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71105-33371105-333-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
c62a10de-a0bc-308c-e053-2995a90a8f5947e0830f-31e4-5ff0-e054-00144ff88e882021-07-02WarningsExact identifier
spl id: c62a10de-a0bc-308c-e053-2995a90a8f59
spl set id: 47e0830f-31e4-5ff0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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