BENTASIL SUGAR FREE BLACKCURRANT SOFT TEXTURE- menthol lozenge

Bentasil by

Drug Labeling and Warnings

Bentasil by is a Otc medication manufactured, distributed, or labeled by CLOETTA ITALIA S.r.l., CLOETTA ITALY SAN PIETRO IN CASALE PLANT. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Phenylketonurics: Contains Phenylalanine (0.9) mg per drop. 3.7 calories per drop

Inactive Ingredients

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

Product Label

INGREDIENTS AND APPEARANCE

BENTASIL  SUGAR FREE BLACKCURRANT SOFT TEXTURE
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63104-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
BETA CAROTENE (UNII: 01YAE03M7J)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
PALM KERNEL OIL (UNII: B0S90M0233)
ACACIA (UNII: 5C5403N26O)
MALTITOL (UNII: D65DG142WK)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	purple (Dark Purple)	Score	no score
Shape	ROUND (Lozenge)	Size	19mm
Flavor	BERRY (Blackcurrant and Menthol)	Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63104-001-20	20 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2014

Labeler - CLOETTA ITALIA S.r.l. (565049314)

Establishment
Name	Address	ID/FEI	Business Operations
CLOETTA ITALY SAN PIETRO IN CASALE PLANT		378806215	manufacture(63104-001)