Maximum Strength Cold, Flu And Sore Throat

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride · Capsule, Liquid Filled · Oral

Over the counter Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pain ▪ sore throat ▪ headache ▪ stuffy nose ▪ sinus congestion and pressure ▪ temporarily reduces fever ▪ temporarily promotes nasal and/or sinus drainage ▪ 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 6 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks everyday 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ 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 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 right away at 1-800-222-1222. 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ 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 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 right away at 1-800-222-1222. 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 6 doses in any 24-hour period ▪ measure only with dosing cup provided. ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ mL = milliliter ▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours ▪ children under 12 years of age: Do not use

Inactive ingredients

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

Questions or comments? 1-866-467-2748

Label text from the FDA structured product label by KROGER COMPANY (revised Sep 2, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Maximum Strength Cold, Flu And Sore Throat NDC products (2)

NDCStrength & formLabelerType
69842-616Guaifenesin 200 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1; Acetaminophen 325 mg/1
Capsule, Liquid Filled
CVS Pharmacy, Inc.OTC MONOGRAPH DRUG
30142-731Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine…
Solution
KROGER COMPANYOTC MONOGRAPH DRUG

Frequently asked questions

What is Maximum Strength Cold, Flu And Sore Throat used for?

Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pain ▪ sore throat ▪ headache ▪ stuffy nose ▪ sinus congestion and pressure ▪ temporarily reduces fever ▪ temporarily promotes nasal and/or sinus drainage ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more…

Who makes Maximum Strength Cold, Flu And Sore Throat?

Maximum Strength Cold, Flu And Sore Throat is listed by 2 labelers in the FDA NDC directory, including CVS Pharmacy, Inc., KROGER COMPANY.