NDC 59105-006 Dextromethorphan Hydrobromide

NDC Product Code 59105-006

NDC CODE: 59105-006

Proprietary Name: Dextromethorphan Hydrobromide 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.

Product Characteristics

Color(s):
RED (C48326)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
404
Score: 1

NDC Code Structure

  • 59105 - J.p. Business Enterprise

NDC 59105-006-15

Package Description: 1 BOTTLE in 1 CARTON > 15 CAPSULE, LIQUID FILLED in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dextromethorphan Hydrobromide with NDC 59105-006 is a product labeled by J.p. Business Enterprise. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1090487.

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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: J.p. Business Enterprise
Labeler Code: 59105
Start Marketing Date: 12-01-2014 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: 12-31-2020 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* 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]

* Please review the disclaimer below.

Dextromethorphan Hydrobromide Product Label Images

Dextromethorphan Hydrobromide 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

Distributed By: J.P Business Enterprise


Lake Grove, NY 11755

Active Ingredient (In Each Liquid-Filled Capsule)

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.

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.

Otc - Ask Doctor

  • Ask a doctor before use if you havea cough that occurs with too much phlegm (mucus)a cough that lasts or is chronic as occurs with smoking, asthma, or emphysematrouble urinating due to an enlarged prostate gland

Otc - Stop Use

Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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 and overtake 2 capsules every 6 to 8 hours, as neededchildren under 12 yearsdo 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 no. 1, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

* Please review the disclaimer below.