NDC 0924-0150 Physicians Care Cough And Sore Throat

Menthol

NDC Product Code 0924-0150

NDC 0924-0150-01

Package Description: 50 CELLO PACK in 1 CARTON > 1 LOZENGE in 1 CELLO PACK

NDC 0924-0150-02

Package Description: 125 CELLO PACK in 1 CARTON > 1 LOZENGE in 1 CELLO PACK

NDC Product Information

Physicians Care Cough And Sore Throat with NDC 0924-0150 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Cough And Sore Throat is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Acme United 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 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.

Physicians Care Cough And Sore Throat 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 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.

  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • SUCROSE (UNII: C151H8M554)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Acme United Corporation
Labeler Code: 0924
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: 01-05-2015 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.

Physicians Care Cough And Sore Throat Product Label Images

Physicians Care Cough And Sore Throat 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

Drug Facts

Active ingredient (in each drop)Menthol 7.6 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 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■ irritation, pain, or redness persists or worsens

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 hour 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

Cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

Physicians Care Cough And Sore Throat Label

Physicians Care®Cough and Sore ThroatCherry Flavored Menthol LozengesPull To OpenIndividually Wrapped Lozenges50 Lozenges (7.6 MG of Menthol Each)

* Please review the disclaimer below.