Severe Cold
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each softgels) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
Uses temporarily relieves these common cold and flu symptoms: headache nasal congestion sore throat cough minor ache and pain temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 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 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. Ask a doctor before use if you have liver disease diabetes high blood pressure heart disease thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking asthma , chronic bronchitis, or emphysema cough that occurs with too much phlegm(mucus) Ask a doctor or pharmacist before use if you are are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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, If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 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 a doctor before use
Ask a doctor before use if you have liver disease diabetes high blood pressure heart disease thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking asthma , chronic bronchitis, or emphysema cough that occurs with too much phlegm(mucus)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are are taking the blood thinning drug warfarin
When using this product
When using this product do not use more than directed
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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,
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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years and older: take 2 softgels every 4 hours children under 12 years of age: do not use
Inactive ingredients
Inactive ingredients FD&C red 40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions?
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Label text from the FDA structured product label by CVS Pharmacy (revised Aug 20, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
- Dextromethorphan Hydrobromide in 2 products
- Guaifenesin in 2 products
- Phenylephrine Hydrochloride in 2 products
Severe Cold NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69842-505 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule | CVS Pharmacy | OTC MONOGRAPH DRUG |
| 41163-053 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | United Natural Foods, Inc. dba UNFI | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Severe Cold used for?
Uses temporarily relieves these common cold and flu symptoms: headache nasal congestion sore throat cough minor ache and pain temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Severe Cold?
Severe Cold is listed by 2 labelers in the FDA NDC directory, including CVS Pharmacy, United Natural Foods, Inc. dba UNFI.