Drug Facts

Active ingredients (in each liquid-filled capsule)

Acetaminophen, USP 325 mg

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

Uses

• temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headachesore throatcoughminor aches and painsrunny nosesneezingitchy, watery eyesitching of the nose or throat
• temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning

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

• more than 8 capsules in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

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

• to sedate a child or to make a child sleepy
• 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking any other pain reliever/fever reducer
• taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

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.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

• do not take more than 8 capsules in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
• this adult product is not intended for use in children under 12 years of age

STORAGE AND HANDLING SECTION

Other information

• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA