NDC 47682-840 Medi-first Honey Lemon Cough Drops

Menthol 8.6 Mg

NDC Product Code 47682-840

NDC Code: 47682-840

Proprietary Name: Medi-first Honey Lemon Cough Drops Additional informationCallout TooltipWhat 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: Menthol 8.6 Mg Additional informationCallout TooltipWhat 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.


Code Structure
  • 47682 - Unifirst First Aid Corporation
    • 47682-840 - Medi-first Honey Lemon Cough Drops

NDC 47682-840-25

Package Description: 125 LOZENGE in 1 BOX

NDC Product Information

Medi-first Honey Lemon Cough Drops with NDC 47682-840 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi-first Honey Lemon Cough Drops is menthol 8.6 mg. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

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 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.


Medi-first 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 8.6 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.

  • CORN SYRUP (UNII: 9G5L16BK6N)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SUCROSE (UNII: C151H8M554)
  • HONEY (UNII: Y9H1V576FH)
  • LEMON OIL (UNII: I9GRO824LL)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 03-18-2019 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.

Medi-first Honey Lemon Cough Drops Product Label Images

Medi-first 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

Other

Drug Facts

Active Ingredient (In Each Drop)

Menthol 8.6 mg

Purpose

Antitussive (cough suppressant)/oral anesthetic

Uses

Temporarily relieves■ cough as may occur with a cold or inhaled irritants■ occasional minor irritation and sore throat

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, 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)

Stop Use And Ask A Doctor If

■ cough 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 mouth does not improve in 7 days■ irritation, pain, or redness persists or worsens

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.

Directions

■ do not use more than directedAdults and children: (12 years and older)Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.Children under 12 years:Do not give to children under 12 years of age.

Other Information

■ 15 calories per drop■ store at 59º-86ºF (15º-30ºC)■ protect from moisture & heat

Inactive Ingredients

Corn syrup, eucalyptus oil, D&C yellow #10, FD&C yellow #6, honey, lemon oil, sucros

Medi-First Cough Drop Label

125dropsMedi-First®Honey LemonCough DropsVapor ActionPull to OpenCough Suppressant • Menthol 8.6 mgCompare active ingredients to:Halls®Registered Trademark of Warner-LambertIndividually Wrapped Cough Drops

Medi-First Plus Honey Lemon Label

125 DropsMedi-First Plus®Honey LemonCough DropsMenthol 8.6 mgPull to OpenCough Suppressant & Anesthetic with Vapor ActionCompare active ingredients to:Halls®Registered Trademark of Warner-LambertIndividually Wrapped Cough Drops

* Please review the disclaimer below.

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