CETAFEN COUGH and COLD
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, , · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 100 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
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
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
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
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
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
Stop use and ask a doctor
Stop use and ask a doctor if 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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
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
Inactive ingredients
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
Label text from the FDA structured product label by HART Health (revised Dec 24, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Guaifenesin in 1 product
- Phenylephrine Hydrochloride in 1 product
- Acetaminophen in 1 product
- Dextromethorphan Hydrobromide in 1 product
CETAFEN COUGH and COLD NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50332-0141 | Guaifenesin 100 mg/1; Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Tablet, Film Coated | HART Health | OTC MONOGRAPH DRUG |
Frequently asked questions
What is CETAFEN COUGH and COLD used for?
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
Who makes CETAFEN COUGH and COLD?
CETAFEN COUGH and COLD is listed by 1 labeler in the FDA NDC directory, including HART Health.