NDC 53345-011 Dextromethorphan Hbr 15 Mg

Dextromethorphan Hbr

NDC Product Code 53345-011

NDC CODE: 53345-011

Proprietary Name: Dextromethorphan Hbr 15 Mg 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: Dextromethorphan Hbr 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.

Product Characteristics

Color(s):
RED (C48326 - CLEAR)
Shape: CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
PC6
Score: 1

NDC Code Structure

  • 53345 - Humanwell Puracap Pharmaceutical (wuhan), Ltd.

NDC 53345-011-01

Package Description: 1 BAG in 1 BOX > 12000 CAPSULE, LIQUID FILLED in 1 BAG

NDC Product Information

Dextromethorphan Hbr 15 Mg with NDC 53345-011 is a a human over the counter drug product labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The generic name of Dextromethorphan Hbr 15 Mg is dextromethorphan hbr. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Humanwell Puracap Pharmaceutical (wuhan), Ltd.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Dextromethorphan Hbr 15 Mg 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 15 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)

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: Humanwell Puracap Pharmaceutical (wuhan), Ltd.
Labeler Code: 53345
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: 01-30-2014 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: 12-31-2021 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.

Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]

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Dextromethorphan Hbr 15 Mg Product Label Images

Dextromethorphan Hbr 15 Mg 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

Active Ingredient (In Each Softgel)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Ask A Doctor Before Use If The User Has

  • A cough that occurs with too much phlegm (mucus)a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Directions

  • Do not take more than 8 capsules in any 24-hour periodthis adult product is not intended for use in children under 12 years of ageadults and children 12 years of age and over     take 2 capsules every 6 to 8 hours, as  neededchildren under 12 years of  age     do not use

Other Information

  • Store at 20-25°C (68-77°F)avoid excessive heat above 40°C (104°F)protect from light

Inactive Ingredients

FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible inkManufactured by:Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.Wuhan, Hubei430206, China

* Please review the disclaimer below.