FDA Label for Severe Congestion, Cough, Cold And Flu Relief Maximum Strength, Nighttime

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

• 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 irritants
    
  • the intensity of coughing
    
  • the impulse to cough to help you get to sleep
    
  • nasal congestion due to a cold
    
  • temporarily relieves these common cold and flu symptoms:
    
    • cough
      
    • headache
      
    • runny nose
      
    • sneezing
      
    • sore throat
      
    • itchy, watery eyes due to hay fever
      
    • itching of the nose or throat
      
    • minor aches and pains
      
    • temporarily reduces fever
      
    • controls cough to help you get to sleep
      
    
    

Do Not Use

• 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.
  
• 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.
  
• if you have ever had an allergic reaction to this product or any of its ingredients
  

Ask A Doctor Before Use If You Have

• heart disease
  
• diabetes
  
• high blood pressure
  
• difficulty in urination due to enlargement of the prostate gland
  
• thyroid disease
  
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  
• cough that occurs with too much phlegm (mucus)
  
• liver disease
  
• glaucoma
  
• cough that occurs with too much phlegm (mucus)
  
• difficulty in urination due to enlargement of the prostate gland
  
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  

When Using This Product

do not exceed recommended dosage.

• do not exceed recommended dosage
  
• excitability may occur, especially in children
  
• avoid alcoholic beverages
  
• marked drowsiness may occur
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• use caution when driving a motor vehicle or operating machinery
  

Stop Use And Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur
  
• symptoms do not get better within 7 days or occur with fever
  
• cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
  
• pain 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 headache that lasts. These could be signs of a serious condition.
  

If Pregnant Or Breast-Feeding,

ask a health professional before use.

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed
  
• do not take more than 6 doses in any 24-hour period
  
• mL = milliliter; FL OZ = fluid ounce
  
• only use the dose cup provided
  
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  
• children under 12 years: do not use
  
• do not take more than directed
  
• do not take more than 4 doses in any 24-hour period
  
• mL = milliliter; FL OZ = fluid ounce
  
• only use the dose cup provided
  
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
  
• children under 12 years: do not use
  

Other Information

• each 20 mL contains: sodium 10 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Questions Or Comments?

1-800-426-9391

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:

• rash
  
• blisters
  
• skin reddening
  

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.

Ask A Doctor Or Pharmacist Before Use If You Are

• taking sedatives or tranquilizers
  
• taking the blood thinning drug warfarin
  

Principal Display Panel

TWO - 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)

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

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Do not take Severe Congestion & Cough and
Nighttime Cold & Flu at the same time.

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-19849

*This product is not manufactured or
distributed by RB Health (US) LLC, owner
of the registered trademark Mucinex®
Maximum Strength FAST-MAX® Severe
Congestion & Cough and Mucinex®
NIGHTSHIFT® Cold & Flu.
50844 ORG0121.004/0222.06345

CVS 44-004063 - cvs 44 004063 1