Maximum Strength Nasal Decongestant

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg)

Inactive Ingredients

Carnauba Wax Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Sodium Starch Glycolate Type A Corn Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 272;S08;T234 Shape: round Color: red Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-11

Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses

■ temporarily relieves sinus congestion and pressure

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

fever or other upper respiratory allergies

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.

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

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN

SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

†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

Structured Label Content

Uses

■ temporarily relieves sinus congestion and pressure

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

fever or other upper respiratory allergies

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.

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 (Other information)

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

Inactive Ingredients (Inactive ingredients)

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrytalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO ACTIVE INGREDIENT IN

SUDAFED® PE CONGESTION®†

MAXIMUM STRENGTH

Nasal Decongestant

· Phenylephrine HCl 10 mg - Nasal Decongestant

†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 (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) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

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)

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Maximum Strength Nasal Decongestant

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information