FDA.reportPublic FDA data

Assured Maximum Strength Nasal Decongestant

Manufacturer
Spirit Pharmaceuticals LLC | Time Cap Laboratories, Inc
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:23

Label at a glance#

ProductAssured Maximum Strength Nasal Decongestant
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

 adults and children 12 years and over  ■ take 1 tablet every 4 hours ■ do not take more than 6 tablets in 24 hours  children under 12 years  ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ 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 occur with a 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)

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 12 years
and over 		 ■ take 1 tablet every 4 hours
■ do not take more than 6 tablets in
24 hours
 children under 12 years ask a doctor

Other information

OTHER SAFETY INFORMATION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED 

COMPARE TO ACTIVE INGREDIENT IN
SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

Relieves Nasal & Sinus Congestion,
Reduces Sinus Pressure, Non-Drowsy

Actual Size

PSEUDOEPHEDRINE FREE

24tablets

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Sudafed PE® Congestion

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN2
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD2

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
68210-0118-32023-01-30C16284748780-1f386c64a-204e-0266-e053-dadaa90a7c1aAssured Maximum Strength Nasal Decongestant 24ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0118-3Assured Maximum Strength Nasal Decongestant1 in 1 CARTONTABLET12
68210-0118-3Assured Maximum Strength Nasal Decongestant24 in 1 BLISTER PACKTABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0118ASSURED MAXIMUM STRENGTH NASAL DECONGESTANT (PHENYLEPHRINE HCL) TABLET [SPIRIT PHARMACEUTICALS LLC]2Legacy NDC, 2 package rows20191227_82d5d61d-8de5-4886-e053-2a91aa0ac831.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-011868210-0118-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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
9aa3946f-406f-482a-e053-2995a90a607282d5d61d-8de5-4886-e053-2a91aa0ac8312019-12-26WarningsExact identifier
spl id: 9aa3946f-406f-482a-e053-2995a90a6072
spl set id: 82d5d61d-8de5-4886-e053-2a91aa0ac831

Reported adverse events (FAERS/openFDA)#

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