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  5. Label Information: Sore Throat

FDA Label for Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR OR DENTIST IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor 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.

Active Ingredient



Phenol 1.4%


Purpose



Oral anesthetic/analgesic


Uses



  • For the temporary relief of occasional minor throat:
  • irritation 
  • pain
  • sore mouth and
  • sore throat

Warnings



Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.


When Using This Product



  • do not exceed recommended dose
  • do not use for more than 2 days, Use only as directed
  • use of this container by more than one person may spread infection

Stop Use And Ask A Doctor Or Dentist If



  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If Pregnant Or Breast-Feeding,



ask doctor before use.


Keep Out Of Reach Of Children.



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


Directions



  • Adults and children 3 years of age and older:
  • Apply to the affected area (one spray)
  • Allow to remain in place for at least 15 seconds, then spit out
  • Use every 2 hours or as directed by a doctor or dentist.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 3 years of age: consult a doctor or dentist
  • Before using the first time, remove the protective neck band and its dust cap from the tip. To spray, hold bottle straight up and press on the nozzle with index finger without tilting head. Fully depress pump all the way down with a firm even stroke. Wipe nozzle dry.

Other Information



  • store at room temperature
  • check expiration date before using
  • retain carton for future reference

Inactive Ingredients



FD&C red #40, flavor, glycerin, purified water, saccharin sodium


Principal Display Panel



Compare to the Active Ingredient in Chloraseptic

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions


* Please review the disclaimer below.