FDA Label for Cvs Maximum Strength Cold And Flu Relief

View Indications, Usage & Precautions

Cvs Maximum Strength Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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.


Otc - 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


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

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.


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.

Otc - Pregnancy Or Breast Feeding



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


Otc - 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 (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.


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

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

     


* Please review the disclaimer below.