NDC 69626-0044 Nice Citrus Cough Drops

Menthol

NDC Product Code 69626-0044

NDC 69626-0044-4

Package Description: 24 LOZENGE in 1 BLISTER PACK

NDC Product Information

Nice Citrus Cough Drops with NDC 69626-0044 is a a human over the counter drug product labeled by Leosons. The generic name of Nice Citrus Cough Drops is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Leosons

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nice Citrus Cough Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 5 mg/1

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.

  • ACESULFAME (UNII: MA3UYZ6K1H)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Leosons
Labeler Code: 69626
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-08-2019 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: 12-31-2020 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nice Citrus Cough Drops Product Label Images

Nice Citrus Cough Drops 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

Otc - Active Ingredient

Active ingredient (in each lozenge)Menthol 5 mg

Otc - Purpose

PurposeCough Suppressant / Oral Anesthetic

Indications & Usage

  • Uses temporarily suppresses / relieves:
  • Coughs due to minor throat and bronchial irritation from a cold or inhaled irritantsoccasional minor sore throat pain

Warnings

  • WarningsAsk a doctor before use if you have chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysemacough that occurs with too much phlegm (mucus)

Otc - When Using

  • When using this productdo not use more than directed, taking more may have a laxative effect

Otc - Stop Use

  • Stop use and ask doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signes of a serious condition.sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomitingsore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directionsdissolve a lozenge slowly in mouthmay be repeated every hour for coughs as needed or as directed by a doctormay be repeated every 2 hours for sore throatdo not take more than 10 lozenges per dayadults and children 6 years and older - 5 mgchildren under 6 years - ask a doctor

Inactive Ingredient

Inactive IngredientsAcesulfame Potassium, Citric Acid, D&C Yellow No. 10, Eucalyptus Oil, Isomalt, Lemon Oil, Other Natural and Artificial Flavors, Sodium Citrate

Otc - Questions

Questions? Call 1-855-452-9500 or email at info@leosonsintl.com

* Please review the disclaimer below.