NDC 49314-0505 Unishield Cherry Cough

Menthol

NDC Product Code 49314-0505

NDC 49314-0505-5

Package Description: 50 LOZENGE in 1 BOX

NDC Product Information

Unishield Cherry Cough with NDC 49314-0505 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Cherry Cough is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Unishield

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.

Unishield Cherry Cough 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, UNSPECIFIED FORM 7.6 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.

  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SUCROSE (UNII: C151H8M554)

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.

Product Labeler Information

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

Labeler Name: Unishield
Labeler Code: 49314
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: 03-01-2021 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: 12-31-2022 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 - NO 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.

Unishield Cherry Cough Product Label Images

Unishield Cherry Cough 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

Otc - Active Ingredient

Active ingredient (in each drop) Menthol 7.6 mg

Otc - Purpose

PurposeAntitussive (cough suppressant)/oral anesthetic

Questions or comments? 800-480-5855

Indications & Usage

  • UsesTemporarily relievescough as may occur with a cold or inhaled irritantsoccasional minor irritation 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, nausea, or vomiting, consult a doctor promptly. These

symptoms may be serious.

Otc - Ask Doctor

  • Ask a doctor before usepersistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessive phlegm (mucus)

Otc - Stop Use

  • Stop use and ask a doctor ifcough 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 daysirritation, pain, or redness persists or worsens

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.

Dosage & Administration

  • Directionsdo 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:Ask a doctor

Other Safety Information

  • Other information15 calories per dropstore at 59º-86ºF (15º-30ºC)protect from moisture & heat

Inactive Ingredient

Inactive ingredients:cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

* Please review the disclaimer below.