assured maximum strength nasal decongestant 24ct

Drug Facts

Composition & Product

Active Ingredients

phenylephrine (10 mg)

Inactive Ingredients

croscarmellose sodium fd&c red no. 40 fd&c yellow no. 6 hypromellose, unspecified lactose, unspecified form magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified silicon dioxide titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 272 Shape: capsule Color: red Size: 8 mm Score: 1

Marketing Status

otc monograph final active Since 2019-02-26

Medication Information

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.

Active Ingredient

Phenylephrine HCl 10 mg

Uses

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay

fever or other upper respiratory allergies

Purpose

Nasal decongestant

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 Information

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

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

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed recommended dose

Section 53413-1

Questions or comments? 1-888-333-9792

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Stop Use and Ask A Doctor If

■ nervousness, dizziness, or sleeplessness occur

■ symptoms do not improve within 7 days or occur with a fever

Ask A Doctor Before Use If You Have

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Uses

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay

fever or other upper respiratory allergies

Purpose

Nasal decongestant

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 Information (Other information)

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

Inactive Ingredients (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

Principal Display Panel (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 53413-1 (53413-1)

Questions or comments? 1-888-333-9792

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ nervousness, dizziness, or sleeplessness occur

■ symptoms do not improve within 7 days or occur with a fever

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies", "42229-5": "Drug Facts", "50565-1": "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)", "50567-7": "When using this product do not exceed recommended dose", "53413-1": "Questions or comments? 1-888-333-9792", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nasal decongestant", "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.", "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 information": "store between 20° to 25°C (68° to 77°F)", "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", "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", "Stop use and ask a doctor if": "■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not improve within 7 days or occur with a fever", "Active ingredient (in each tablet)": "Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland"}

assured maximum strength nasal decongestant 24ct

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information