Cough and Cold (acetaminophen 250 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

Active Ingredients (in Each Capsule)

Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg

Phenylepherine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Antitussive (cough suppressant)

Nasal decongestant

Uses

temporarily relieves: ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ runny nose ▪ sneezing ▪ itching of the nose or throat

â–ª itchy, watery eyes due to hay fever or other upper respiratory allergies â–ª nasal congestion â–ª cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take â–ª more than 12 capsules in 24 hours, which is the maximum daily amount â–ª with other drugs containing acetaminophen â–ª 3 or more alcoholic drinks every day while using this product

Do not exceed recommended dosage

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 allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage ▪ 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 ▪ for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor ▪if you are taking sedatives or tranquilizers, without first consulting your doctor.

Ask A Doctor Before Use If You Have

â–ª liver disease â–ª a breathing problem such as emphysema or chronic bronchitis â–ª glaucoma â–ª heart disease â–ª high blood pressure

▪ thyroid disease ▪ diabetes ▪ difficulty in urination due enlargement of the prostate gland.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

When Using This Product

â–ª excitability may occur, especially in children â–ª may cause drowsiness â–ª alcohol, sedatives and tranquilizers may increase drowsiness effect

â–ª use caution when driving a motor vehicle or operating machinery â–ª avoid alcoholic beverages

Stop Use And Ask A Doctor If

▪ pain, nasal congestion or cough 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 ▪ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occur.

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. 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) ▪ do not use for more than 10 days unless directed by a doctor ▪ Adults and children 12 years of age and over ▪ take 2 capsule every 4 hours. ▪ do not take more than 12 capsules in 24 hours ▪ Children under 12 years of age ▪ do not use this adult product in children under 12 years of age; this will provide more than recommended dose (overdoes) and may cause liver damage.

Other Information

Store at room temperature in a dry place

Inactive Ingredients

DC red no. 33, FDC blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, water

Package Label