Phenylephrine Hydrochloride, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin
FDA Drug Information • Also known as: Cold Terminator Cold Relief
- Brand Names
- Cold Terminator Cold Relief
- Drug Class
- Expectorant [EPC]
- Route
- ORAL
- Dosage Form
- TABLET, FILM COATED
- Product Type
- HUMAN OTC DRUG
What Is Phenylephrine Hydrochloride, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin Used For?
INDICATIONS & USAGE Uses Temporarily relieves these symptoms due to the common cold: headache nasal congestion cough minor aches and pains sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive Temporarily reduces fever.
Dosage and Administration
DOSAGE & ADMINISTRATION Directions do not take more than directed Adults and children: (12 years and over) take 2 caplets every 4 hours not to take more than 10 caplets in 24 hours Children under 12 years: ask a doctor
Warnings and Precautions
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: blisters rash skin reddening If a skin 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 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 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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ASK DOCTOR 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 cough that occurs with too much phlegm (mucus) persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. WHEN USING When using this product do not exceed recommended dosage. STOP USE Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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. 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. DOSAGE & ADMINISTRATION Directions do not take more than directed Adults and children: (12 years and over) take 2 caplets every 4 hours not to take more than 10 caplets in 24 hours Children under 12 years: ask a doctor
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.