NDC 72628-101 Honey Lemon Cough Drops

Menthol

NDC Product Code 72628-101

NDC Product Information

Honey Lemon Cough Drops with NDC 72628-101 is a a human over the counter drug product labeled by Boston Nutraceutical Production Sl. The generic name of Honey Lemon Cough Drops is menthol. The product's dosage form is pastille and is administered via oral form.

Labeler Name: Boston Nutraceutical Production Sl

Dosage Form: Pastille - An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Honey Lemon Cough Drops Active Ingredient(s)

Additional informationCallout TooltipWhat 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 7.6 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LEMON OIL (UNII: I9GRO824LL)
  • HONEY (UNII: Y9H1V576FH)
  • ISOMALT (UNII: S870P55O2W)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
  • TURMERIC (UNII: 856YO1Z64F)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Boston Nutraceutical Production Sl
Labeler Code: 72628
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-26-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Honey Lemon Cough Drops Product Label Images

Honey Lemon 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 drop PurposesMenthol 7.6 mg Cough Suppressant Oral anesthetic

Otc - Purpose

PurposesCough suppressant/Oral anesthetic

Indications & Usage

  • Uses Temporarily relieves:cough as may occur with cold or inhaled irritantsocassional minor irritations and sore throat

Warnings

WarningsSore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious.

Otc - Ask Doctor

Ask a doctor before use if you havepersistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessvie phlegm (mucus)

Otc - Stop Use

  • Stop use and consult doctor ifcough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.sore throat is severe, or irritation, pain or redness last or worsenssore mouth does not improve in 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Overdosage

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsAdults and children 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.Children under 5 years: ask a doctor

Other Safety Information

  • Other information6 calories per dropMay be useful for diabetics on the advise of a doctorExcessive consumption may cause laxative effect

Inactive Ingredient

Citric acid, eucalyptus oil, isomalt, stevia, flavor lemon oil, flavor honey extract, colorant turmeric, water

Otc - Questions

Questions or comments call: 617-848-4560

* Please review the disclaimer below.

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