Comtrex® Cough & Cold Day/Night

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

• temporarily relieves these common cold/flu symptoms:headacheminor aches and painsnasal congestionsinus congestion and pressuresore throatcoughsneezing and runny nose (Cold Night only)
• helps clear nasal passages
• temporarily reduces fever
• promotes nasal and sinus drainage (Cold Day only)
• relieves cough to help you sleep (Cold Night only)

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Ask a doctor before use if you have

• diabetes
• high blood pressure
• heart disease
• thyroid disease
• liver disease
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)
• glaucoma (Cold Night only)
• a breathing problem such as emphysema or chronic bronchitis (Cold Night only)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Cold Night only)

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks (Cold Night only)
• marked drowsiness may occur (Cold Night only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Cold Night only)
• excitability may occur, especially in children (Cold Night only)
• be careful when driving a motor vehicle or operating machinery (Cold Night only)

Stop use and ask a doctor if

These could be signs of a serious condition.

• fever gets worse or lasts more than 3 days
• new symptoms occur
• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
• redness or swelling is present

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.

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 (1-800-222-1222) right away. 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)
• adults and children 12 years and over:take 2 caplets every 4 hoursswallow whole - do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• see end flap for expiration date and lot number
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients (Cold Day)

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, sucralose, titanium dioxide, triacetin

Inactive ingredients (Cold Night)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide