FDA Label for Chloraspetic

View Indications, Usage & Precautions

Chloraspetic Product Label

The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, 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 Ingredients (In Each Lozenge)



Benzocaine 6 mg

Menthol 10 mg


Purpose



Oral pain reliever

Oral pain reliever


Uses



Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.


Warnings



Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor.


Do Not Use



  • for teething
  • in children under 6 years of age

When Using This Product



do not exceed recommended dosage.


Stop Use And Ask A Dentist Or Doctor 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 a health care professional before use.  


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



Adults and children 6 years of age and older: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.

Children under 6 years of age: Do not use.


Other Information



  • Contains FD&C yellow no. 5 (tartrazine) as a color additive.
  • Store between 15C - 30C (59F - 86F)
  • Protect from moisture.
  • Check expiration date before using.

Inactive Ingredients



corn syrup, FD&C yellow no. 5, glycerin, honey, propylene glycol, soy lecithin, sucrose, water


Questions



1-800-552-7932 Chloraseptic.com


Principal Display Panel



Chloraseptic®

Sore throat

18 lozenges | Honey Lemon With real honey


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