Cvs Maximum Strength Cold & Flu Relief

Cvs Maximum Strength Cold & Flu Relief
SPL v7
SPL
SPL Set ID cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5
Route
ORAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-11

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
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

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
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.
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 reddening
  • blisters
  • rash.

If a skin reaction occurs, stop use and seek medical help right away.

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.

Other Information
  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate
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 Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu

NDC 69842-566-06

Maximum Strength‡

Cold , Flu &

Sore Throat

Acetaminophen -Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Controls Cough, Thins & Loosens Mucus
  • Nasal & Chest Congestion
  • Sinus Pressure & Congestion
  • Body Pain, Headache, Fever & Sore Throat

For Ages 12+

6 FL OZ (180 mL)

Do not use if printed seal under cap is broken or missing.

‡ Per 4-hour dose.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength‡ Mucinex® Fast-Max® Cold, Flu & Sore Throat

 

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.
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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
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

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
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.
Liver Warning: (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 reddening
  • blisters
  • rash.

If a skin reaction occurs, stop use and seek medical help right away.

Overdose Warning (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.

Other Information (Other information)
  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate
Inactive Ingredients (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 Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu

NDC 69842-566-06

Maximum Strength‡

Cold , Flu &

Sore Throat

Acetaminophen -Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Controls Cough, Thins & Loosens Mucus
  • Nasal & Chest Congestion
  • Sinus Pressure & Congestion
  • Body Pain, Headache, Fever & Sore Throat

For Ages 12+

6 FL OZ (180 mL)

Do not use if printed seal under cap is broken or missing.

‡ Per 4-hour dose.

Distributed by:

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength‡ Mucinex® Fast-Max® Cold, Flu & Sore Throat

 

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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