Cetafen Cough And Cold Tablet, Film Coated
FDA Label NDC 50332-0141

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold and flu symptoms

• cough
• sore throat
• headache
• minor aches and pains
• nasal congestion
• sinus congestion and pressure
• helps loosen phlegm (mucus) and bronchial secretions to coughs more productive

Temporarily reduces fever

Warnings

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 reactions. Symptoms may include:

• 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 right away.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription)
• if you have ever had an allergic reaction to this product or any of its ingredients
• 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, or if you do not know if your prescription drug contains an MAOI

Ask a doctor before use if you have

• heart, liver, or thyroid disease
• high blood pressure
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate 
• a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts 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
• you do not know if other drugs you are taking contain acetaminophen

• an allergic reaction occurs, seek medical help right away
• redness or swelling is present
• you get nervous, dizzy, or sleepless
• new symptoms occur
• fever worsens or lasts more than 3 days
• pain, nasal congestion, or cough worsens or lasts more than 7 days
• cough comes back or occurs with a rash or headache that lasts

These could be signs of a serious condition.

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

Keep out of reach of children.

Directions

Do not take more than directed

Adults and children 12 years of age and over

• take 2 caplets every 6 to 8 hours while symptoms persist
• do not take more than 8 caplets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Other information:

• caplets enclosed in a sealed packet
• do not use if packet is torn, cut or open
• store at 59° to 86°F (15°-30°C)
• avoid excessive heat and humidity

Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide