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  5. Label Information: Cvs Sore Throat Mixed Berry Flavor

FDA Label for Cvs Sore Throat Mixed Berry Flavor

View Indications, Usage & Precautions

Table of Contents

    1. CVS SORE THROAT MIXED BERRY FLAVOR
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTHER
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    7. STOP USE AND ASK A DOCTOR OR DENTIST  IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS ?
    14. CVS SORE THROAT LOZENGES MIXED BERRY FLAVOR 18 COUNT (59779-649-18)

Cvs Sore Throat Mixed Berry Flavor 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.

Cvs Sore Throat Mixed Berry Flavor




Otc - Purpose



Active ingredients (in each lozenge)Purpose
Benzocaine 7.5 mgOral Pain Reliever

Dextromethorphan hydrobromide 5 mg

Oral Pain Reliever

Uses



temporarily relieves these symptoms:

  • occasional minor irritation, pain, sore mouth and sore throat
  • pain associated with canker sores
  • cough due to minor throat and bronchial irritation as may occur with common cold

Otc - Do Not Use



Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.


Other



Sore throat warning:

Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

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.


Ask A Doctor Before Use If You Have:



• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

• cough that occurs with too much phlegm (mucus)


Stop Use And Ask A Doctor Or Dentist  If



  • sore mouth symptom do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling developes
  • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 this and all drugs out of the reach of children.

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


Directions



  • adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow to dissolve slowly in the mouth. May be repeated every 4 hours, not to exceed 6 lozenges in 24-hours, or as directed by a doctor

    • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours

      • children 6 years of age: do not use


Other Information



  • store at room temperature
  • protect from moisture

Inactive Ingredients



Acesulfame potassium, corn syrup, FD&C Blue #1, FD&C Red #40, natural and artificial flavors (medium chain triglycerides), propylene glycol, sucrose, and water.  Soybean oil and corn starch used as processing aids.


Questions ?



Call 1-800-245-2898. Monday through Friday, 9AM - 4PM EST. 


Cvs Sore Throat Lozenges Mixed Berry Flavor 18 Count (59779-649-18)



CVS pharmacy

compare to the active ingredients in Cepacol**

SORE THROAT &

COUGH LOZENGES

SOOTHING RELIEF

BENZOCAINE 7.5 mg/DEXTROMETHORPHAN HBr 5 mg

Temporarily relieves:

  • Minor sore throat &mouth irritation
  • Cough due to minor throat irritation

    • Mixed Berry Flavor

    18 LOZENGES

    DISTRIBUTED BY:

    CVS Pharmacy, Inc.

    One Cvs Drive Woonsocket, RI 02895

    2014 CVS/Pharmacy

    CVS.com    1-800-SHOP CVS

    Made in the USA

    This product is not manufactured or distributed

    by Reckftt Bencldser owner af the registered

    trademark Cepacol.

    front - front

    front - front


* Please review the disclaimer below.