NDC 63104-003 Bentasil Sugar Free Eucalyptus Soft Texture

NDC Product Code 63104-003

NDC CODE: 63104-003

Proprietary Name: Bentasil Sugar Free Eucalyptus Soft Texture What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
GREEN (C48329 - AQUA)
Shape: ROUND (C48348)
Size(s):
19 MM
Score: 1
Flavor(s):
MENTHOL (C73403 - EUCALYPTUS AND MENTHOL)

NDC Code Structure

  • 63104 - Cloetta Italia S.r.l.

NDC 63104-003-20

Package Description: 20 LOZENGE in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Bentasil Sugar Free Eucalyptus Soft Texture with NDC 63104-003 is a product labeled by Cloetta Italia S.r.l.. The generic name of Bentasil Sugar Free Eucalyptus Soft Texture is . The product's dosage form is and is administered via form.

Labeler Name: Cloetta Italia S.r.l.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ASPARTAME (UNII: Z0H242BBR1)
  • 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 Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cloetta Italia S.r.l.
Labeler Code: 63104
Start Marketing Date: 04-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Bentasil Sugar Free Eucalyptus Soft Texture Product Label Images

Bentasil Sugar Free Eucalyptus Soft Texture Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Menthol 5.8mgEucalyptus 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

* Please review the disclaimer below.