FDA Label for Bentasil Sugar Free Eucalyptus Soft Texture

View Indications, Usage & Precautions

Bentasil Sugar Free Eucalyptus Soft Texture Product Label

The following document was submitted to the FDA by the labeler of this product Cloetta Italia S.r.l.. 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



Menthol 5.8mg

Eucalyptus oil 5.7mg


Purpose



Cough Suppressant,

Oral Anesthetic


Uses



•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold


Warnings



Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a 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 Ask A Doctor If



•cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens 


Directions



•adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

•children under 5 years: ask a doctor


Other Information



• Phenylketonurics: Contains Phenylalanine (1.3) mg per drop. •3.2 calories per drop


Inactive Ingredients



•aspartame (contains phenylalanine), carnauba wax, citric acid, coconut and or palm kernel oil, flavor, gum arabic, maltitol, sorbitol, xylitol


Product Label




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