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  5. Label Information: Cold Flu And Sore Throat

FDA Label for Cold Flu And Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 20 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Cold Flu And Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.

Active Ingredients (In Each 20 Ml)



Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Purposes



Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Uses



  • •temporarily relieves these common cold and flu symptoms:
  • •cough
  • •nasal congestion
  • •minor aches and pains
  • •sore throat
  • •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

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:

    • •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.


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.
  • •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



  • •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 headache that lasts. 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.



Overdose warning: 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 do not notice any signs or symptoms.


Directions



  • •do not take more than directed (see Overdose warning)
  • •do not take more than 5 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 7 mg
  • •store at 20-25°C (68-77°F)
  • •dosing cup provided
  • •do not refrigerate

Inactive Ingredients



anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triethyl citrate, xanthan gum


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to the active ingredients in Mucinex® Fast-Max® Cold, Flu & Sore Throat

ADULT

Cold, Flu & Sore Throat

ACETAMINOPHEN – Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

GUAIFENESIN – Expectorant

PHENYLEPHRINE HCl – Nasal decongestant

MAXIMUM STRENGTH

Multi-Symptom

Relieves headache, fever & sore throat

Controls cough

Relieves nasal & chest congestion

Thins & Loosens mucus

For Ages 12 & Over

6 FL OZ (180 mL)

adult-cold-flu-&-sore-throat-image - image 01

adult-cold-flu-&-sore-throat-image - image 01


* Please review the disclaimer below.