Assured Maximum Strength Nasal Decongestant 24ct

Set ID
82d5d61d-8de5-4886-e053-2a91aa0ac831
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

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

Uses

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

Warnings

Warnings

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

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

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not improve within 7 days or occur with a fever

Directions And Dosage

Directions

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 Label Information

Inactive ingredients

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

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

Products

NDC Codes

Ingredients

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

Complete SPL Sections

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

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

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

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc9aa3946f-406f-482a-e053-2995a90a6072.xml2019-12-27
otc82d6227b-18d3-b0cd-e053-2991aa0a2a77.xml2019-02-27
otcAssured Nasal Decongestant 24 tablets.jpg2019-02-27