Bentasil description, usages, side effects, indications, overdosage, supplying and lots more!

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Bentasil

CLOETTA ITALIA S.r.l.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Menthol 5mg

Cough Suppressant, Oral Anesthetic

•for the temporary relief of minor sore throat

•for the temporary relief of coughs due to a cold

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)

•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 

•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

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

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

Product Label

Bentasil

Bentasil

Menthol LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63104-001
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 5 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
Beta Carotene
carnauba wax
CITRIC ACID MONOHYDRATE
COCONUT OIL
PALM KERNEL OIL
ACACIA
MALTITOL
sorbitol
Xylitol

Product Characteristics

Color Size Imprint Code Shape
purple (Dark Purple) 19 mm NONE ROUND

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
part part341 2014-04-01


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