TYLENOL SINUS

McNeil Consumer Healthcare Div McNeil-PPC, Inc

TYLENOL SINUS CONGESTION AND PAIN

FULL PRESCRIBING INFORMATION: CONTENTS*

• TYLENOL SINUS Uses
• Warnings
  • Liver warning
  • Overdose warning
• Directions
• TYLENOL SINUS Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

TYLENOL SINUS Uses

• for the temporary relief of:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 gelcaps in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

TYLENOL SINUS Other information

• store between 20-25°C (68-77°F). Avoid high humidity.
• do not use if carton is opened or if blister unit is broken
• see side panel for lot number and expiration date

Inactive ingredients

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C blue #2, FD&C red #40, gelatin, hypromellose, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-229-24

See New Warnings Information

TYLENOL ^®

SINUS
CONGESTION & PAIN

Alleviates Sinus Headache & Pain
Acetaminophen

Relieves Sinus Pressure
Clears Nasal Congestion
Phenylephrine HCl

24 RR GELCAPS

Rapid Release
GELS

DAYTIME
Non-Drowsy