CETAFEN COUGH and COLD
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves these cold and flu symptoms
Temporarily reduces fever
- 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
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
- 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
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - STOP USE SECTION
These could be signs of a serious condition.
- 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
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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions
Do not take more than directed
Adults and children 12 years of age and over
Children under 12 years of age: ask a doctor
- 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
OTHER SAFETY INFORMATION
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 INGREDIENT SECTION
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