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CVS Maximum Strength Cold and Flu Relief drug information

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL
CVS PHARMACY · ORAL

Product NDC: 69842-903

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Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL
Labeler / manufacturerCVS PHARMACY
RouteORAL
Drug classExpectorant
Product NDC69842-903
Label effective date2026-08-19

Official product label reference

CVS Maximum Strength Cold and Flu Relief — CVS PHARMACY

This page contains 16 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL, oral route. Label set e1c246a4-7a8c-4761-ab26-13b5165029cc, version 10.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pains ▪ sore throat ▪ sinus congestion and pressure ▪ headache ▪ 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

Purpose

Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Table text from source: | Active ingredients (in each 20 mL) | Purposes | | Acetaminophen 650 mg | Pain reliever/fever reducer | Dextromethorphan HBr 20 mg | Cough suppressant | Guaifenesin 400 mg | Expectorant | Phenylephrine HCl 10 mg | Nasal decongestant
Dosage and administration — label text
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 ▪ 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
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 daily while using this product Generic Section Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin ▪ 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. ▪ for children under 12 years of age ▪ 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 rash, or persistent headache. 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.
Unclassified section
Drug Facts 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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.
Active ingredient
Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Table text from source: | Active ingredients (in each 20 mL) | Purposes | | Acetaminophen 650 mg | Pain reliever/fever reducer | Dextromethorphan HBr 20 mg | Cough suppressant | Guaifenesin 400 mg | Expectorant | Phenylephrine HCl 10 mg | Nasal decongestant
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. ▪ for children under 12 years of age ▪ 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
While using this medicine
When using this product do not use more than directed
When to stop use and seek help
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 rash, or persistent headache. These could be signs of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children.
Storage and handling
Other information ▪ each 20 mL contains: sodium 8 mg ▪ store at room temperature ▪ do not refrigerate
Inactive ingredient
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions
Questions or comments? 1-866-467-2748

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

RxNorm identifiers: 1116572

Package NDC codes

69842-903-09, 69842-903-06

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.