BENTASIL SUGAR FREE HONEY LEMON SOFT TEXTURE- menthol lozenge 
CLOETTA ITALIA S.r.l.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Menthol 5mg

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

Keep out of reach of children

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

• 3.1 calories per drop

Inactive Ingredients

•Ammonium glycrrhizate, carnauba wax, coconut and or palm kernel oil, flavoring, gum arabic, maltitol, sorbitol

Product Label

image description

BENTASIL  SUGAR FREE HONEY LEMON SOFT TEXTURE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63104-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
COCONUT OIL (UNII: Q9L0O73W7L)  
PALM KERNEL OIL (UNII: B0S90M0233)  
ACACIA (UNII: 5C5403N26O)  
MALTITOL (UNII: D65DG142WK)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Coloryellow (Amber) Scoreno score
ShapeROUND (Lozenge) Size19mm
FlavorHONEY (Honey and Lemon) Imprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63104-004-2020 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2014
Labeler - CLOETTA ITALIA S.r.l. (565049314)
Establishment
NameAddressID/FEIBusiness Operations
CLOETTA ITALY SAN PIETRO IN CASALE PLANT378806215manufacture(63104-004)

Revised: 4/2014
Document Id: bb51f005-43c0-49f4-9217-7c1011c442a4
Set id: 6a1adcfd-112a-44b6-a7cb-b18c9093b1f6
Version: 1
Effective Time: 20140417
 
CLOETTA ITALIA S.r.l.