NDC 11822-0043 Rite Aid Mixed Berry Sore Throat And Cough Lozenge

Benzocaine

NDC Product Code 11822-0043

NDC Code: 11822-0043

Proprietary Name: Rite Aid Mixed Berry Sore Throat And Cough Lozenge What 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: Benzocaine What 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.

NDC Code Structure

  • 11822 - Rite Aid
    • 11822-0043 - Rite Aid Mixed Berry Sore Throat And Cough Lozenge

NDC 11822-0043-1

Package Description: 18 LOZENGE in 1 BLISTER PACK

NDC Product Information

Rite Aid Mixed Berry Sore Throat And Cough Lozenge with NDC 11822-0043 is a a human over the counter drug product labeled by Rite Aid. The generic name of Rite Aid Mixed Berry Sore Throat And Cough Lozenge is benzocaine. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Rite Aid

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.

Rite Aid Mixed Berry Sore Throat And Cough Lozenge 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.

  • BENZOCAINE 7.5 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 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.

  • WATER (UNII: 059QF0KO0R)

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: Rite Aid
Labeler Code: 11822
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-18-2019 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.

Rite Aid Mixed Berry Sore Throat And Cough Lozenge 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 ingredients (in each lozenge)Benzocaine 7.5 mgDextromethorphan Hydrobromide 5 mg

Otc - Purpose

PurposesOral Pain RelieverCough Suppressant

Indications & Usage

  • Uses temporarily relieves these symptms:
  • Occasional minor mouth irritation, sore mouth and sore throatcough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

  • WarningsMethemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:pale, gray, or blue colored skin (cyanosis)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energySore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
  • Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

Otc - Do Not Use

  • Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • For teethingin children under 2 years of age

Otc - Ask Doctor

  • Ask a doctor before use if you have:persistent of chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)

Otc - Stop Use

  • Stop use and ask a doctor ifsore mouth symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling developscough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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

Dosage & Administration

Directionsadults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctorchildren 6 to 12 years of age - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctorchildren under 6 years of age - do not use

Other Safety Information

  • Other informationstore at room temperatureprotect from moisture

Inactive Ingredient

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, FD&C blue no.1, FD&C red no. 40, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

Otc - Questions

Questions? Or to report an adverse event call
1-800-245-2898, Monday - Friday, 9AM to 4PM EST

* Please review the disclaimer below.

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