Alka-Seltzer Plus Severe Sinus Cold and Cough (acetaminophen 250 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

Drug Facts

Active Ingredients (in Each Capsule)

Active ingredients (in each capsule)	Purposes
Acetaminophen 250 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine hydrochloride 5 mg	Nasal decongestant

Purposes

Uses

• temporarily relieves these symptoms due to a cold:

· nasal congestion

· sinus congestion and pressure

· headache

· minor aches and pains

· cough

· sore throat

• temporarily restores freer breathing through the nose
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily reduces fever

Warnings

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

• more than 12 capsules in 24 hours, which is the maximum daily amount for this product
• 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
• bulers
• 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.

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
• in children under 12 years of age

Ask A Doctor Before Use If You Have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough with excessive phlegm (mucus)

Otc - Ask Doctor/pharmacist Section

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

Otc - When Using Section

When using this product do not exceed recommended dosage

Stop Use And Ask A Doctor If

• 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 fever, rash or headache that lasts. These could be signs of a serious condition.
• nervousness, dizziness, or sleeplessness occurs

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

Other Information

• store at 15-25ºC (59-77ºF)

Inactive Ingredient Section

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol-sorbitan solution, titanium dioxide

Otc - Questions Section

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)