FDA Label for Leader Sugar Free Cough Drops Black Cherry

View Indications, Usage & Precautions

Leader Sugar Free Cough Drops Black Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Leader Sugar Free Cough Drops Black Cherry





Active Ingredient (In Each Drop)



Menthol 5.8 mg


Purpose



Cough suppressant/Oral anesthetic


Uses



temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

Warnings Sore Throat Warning:



if sore throat is severe, persists for more than 2 days, is accompanied or followed be fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.


Ask A Doctor Before Use If You Have:



  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

When Using This Product



  • do not exceed recommended dosage

Stop Use And Consult Doctor If



  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep This And All Drugs Out Of The Reach Of Children.



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


Directions



adults and children
5 years and over
allow 1 drop to dissolve slowly in mouth.
May be replaced every two hours as necessary or as directed by a doctor.
children under 5 years
ask a doctor

Other Information:



  • 10 calories per drop

Inactive Ingredients:



acesulfame potassium, blue no. 1, eucalyptus oil, flavoring, hydrogenated starch hydrolysate, isomalt, red no. 40, sucralose and water. Soybean oil used as a processing aid.


Questions?



Or to report an adverse event call 1-800-200-6313. Monday - Friday, 9AM to 4PM EST


Distributed By



CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 4562393 www.myleader.com 1-800-200-6313

UD Certified GF Gluten-Free

* This product is not manufactured or distributed by Kraft, owner of the registered trademark HallsR, or by any of its affiliates.


Leader Sugar Free Cough Drops Black Cherry 25 Count (49781-043-25)




* Please review the disclaimer below.