Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate Capsule, Liquid Filled
FDA Label NDC 35916-0189

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Doxylamine Succinate USP 6.25 mg

Pain reliever/fever reducer

Cough suppressant

Antihistamine

• temporarily relieves these symptoms due to a cold or flu :

• minor aches and pains • headache • cough

• sore throat • nasal and sinus congestion

• temporarily reduces fever

Liver warning: This product contains acetaminophen. 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

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening • blisters • rash • hives

• facial swelling • asthma (wheezing) • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away

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.

• 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

• in children under 12 years of age

• liver disease • heart disease • high blood pressure

• thyroid disease • diabetes

• cough that occurs with excessive phlegm (mucus)

• difficulty in urination due to enlargement of the prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

• pain, cough, 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

• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

• nervousness, dizziness, or sleeplessness occurs

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

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.

• do not take more than the recommended dose

• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.

• children under 12 years: do not use

• store at room temperature. Avoid excessive heat above 40°C (104°F).

D&C yellow no.10, FD&C blue no.1, gelatin, glycerin, mica, polyethylene glycol 400, povidone K 30, purified water, sorbitol sorbitan solution, titanium dioxide