Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 91c803c8-6cf8-4ff6-b376-ea6d65f9f227
Route
ORAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg) Acetaminophen (650 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Propylene Glycol Water Trisodium Citrate Dihydrate Fd&c Blue No. 1 Glycerin Propyl Gallate Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-30 Until 2027-01-30

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritant
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold

Nighttime

  •  temporarily relievesthese common cold and flu symptoms
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • temporarily reduces fever
    • controls cough to help you get to sleep
Warnings

 Nighttime

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.

Directions

Daytime

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  •  mL= milliliter
  • shake well before using
  • adult and children 12 years of age and older: 20 mL in dosing cup provided avery 4 hours
  • Children under 12 years of age do not use



Nighttime

  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses in any24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL= milliliter
  • dose as follows or as directed by a doctor
  • adult and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use 


Do Not Use

Daytime

  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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.
  • for children under 12 years of age

Nighttime

  • With any other drug containing acetaminophen (prescription or nonprescription ). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
  • for children under 12 years of age
Product Label
CVS HEALTH Severe Cough & Congestion Nighttime Cold & Flu
Other Information

Daytime

  • each 20 mL contains: sodium 17 mg
  • store at 20-25ºC (68-77ºF). Do not refrigerate.

Nighttime

  • each 20 mL contains: sodium 10 mg
  • store at 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

Inactive ingredients for Day Time  

 citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, flavor, glycerin, propyl gallate,  propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose,xanthan gum

Inactive ingredients for Night Time  

 citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Purposes for Day Time

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Principal Display Panel

DAYTIME

Severe Cough & Congestion

DEXTROMETHORPHAN HBr - Cough Suppressant

GUAIFENESIN -  Expectorant

PHENYLEPHRINE HCI - Nasal Decongestant

MAXIMUM STRENGTH

Multi-Symptom

  • Relieves nasal & chest congestion
  • Soothes Cough 
  • Thins & loosen mucus

For ages 12 & over

FL OZ (mL)

Compare to the active ingredients in Maximum Strength Mucinex®FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu*

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough & Nighttime Cold & Flu

NIGHTTIME

Cold & FLU

ACETAMINOPHEN - Pain Reliever ; Fever Reducer

DIPHENHYDRAMINE HCl -  Antihistamine / Cough Suppressant

PHENYLEPHRINE HCl / Nasal Decongestant

MAXIMUM STRENGTH

Multi-Strength

  • Relieves headache & fever
  • Controls cough
  • Relieves nasal congestion
  • Relieves runny nose & sneezing

For ages 12 & over

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

When Using This Product

Daytime

do not use more than directed.

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsinessmay occur
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last 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,

Daytime

 ask a health professional before use

Nighttime

ask a health professional before use

Keep Out of Reach of Children.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Nighttime

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 adult as well as for children even if you do not notice any signs or symptoms

Ask A Doctor Before Use If You Have

Daytime

  • 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, emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

Nighttime

  • you are taking the blood thinning drug warfain
  • you are taking sedatives or tranquilizers
Active Ingredients for Day Time (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients for Night Time (in Each 20 Ml)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg


Structured Label Content

Uses

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritant
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold

Nighttime

  •  temporarily relievesthese common cold and flu symptoms
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • temporarily reduces fever
    • controls cough to help you get to sleep
Warnings

 Nighttime

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.

Directions

Daytime

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  •  mL= milliliter
  • shake well before using
  • adult and children 12 years of age and older: 20 mL in dosing cup provided avery 4 hours
  • Children under 12 years of age do not use



Nighttime

  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses in any24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • mL= milliliter
  • dose as follows or as directed by a doctor
  • adult and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use 


Do Not Use (Do not use)

Daytime

  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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.
  • for children under 12 years of age

Nighttime

  • With any other drug containing acetaminophen (prescription or nonprescription ). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
  • for children under 12 years of age
Product Label
CVS HEALTH Severe Cough & Congestion Nighttime Cold & Flu
Other Information (Other information)

Daytime

  • each 20 mL contains: sodium 17 mg
  • store at 20-25ºC (68-77ºF). Do not refrigerate.

Nighttime

  • each 20 mL contains: sodium 10 mg
  • store at 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

Inactive ingredients for Day Time  

 citric acid, disodium EDTA, FD&C blue #1 FD&C red #40, flavor, glycerin, propyl gallate,  propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose,xanthan gum

Inactive ingredients for Night Time  

 citric acid, EDTA disodium, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Purposes for Day Time

Cough suppressant

Expectorant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Principal Display Panel

DAYTIME

Severe Cough & Congestion

DEXTROMETHORPHAN HBr - Cough Suppressant

GUAIFENESIN -  Expectorant

PHENYLEPHRINE HCI - Nasal Decongestant

MAXIMUM STRENGTH

Multi-Symptom

  • Relieves nasal & chest congestion
  • Soothes Cough 
  • Thins & loosen mucus

For ages 12 & over

FL OZ (mL)

Compare to the active ingredients in Maximum Strength Mucinex®FAST-MAX® Severe Congestion & Cough and Nighttime Cold & Flu*

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Severe Congestion & Cough & Nighttime Cold & Flu

NIGHTTIME

Cold & FLU

ACETAMINOPHEN - Pain Reliever ; Fever Reducer

DIPHENHYDRAMINE HCl -  Antihistamine / Cough Suppressant

PHENYLEPHRINE HCl / Nasal Decongestant

MAXIMUM STRENGTH

Multi-Strength

  • Relieves headache & fever
  • Controls cough
  • Relieves nasal congestion
  • Relieves runny nose & sneezing

For ages 12 & over

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

When Using This Product (When using this product)

Daytime

do not use more than directed.

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsinessmay occur
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • avoid alcohol drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last 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, (If pregnant or breast-feeding,)

Daytime

 ask a health professional before use

Nighttime

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Nighttime

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 adult as well as for children even if you do not notice any signs or symptoms

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Daytime

  • 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, emphysema
  • cough that occurs with too much phlegm (mucus)

Nighttime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • 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)

Nighttime

  • you are taking the blood thinning drug warfain
  • you are taking sedatives or tranquilizers
Active Ingredients for Day Time (in Each 20 Ml) (Active ingredients for Day Time (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Active Ingredients for Night Time (in Each 20 Ml) (Active ingredients for Night Time (in each 20 mL))

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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