NDC 45014-151 Cough And Cold

NDC Product Code 45014-151

NDC CODE: 45014-151

Proprietary Name: Cough And Cold 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: 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 - REDDISH-PINK)
PINK (C48328)
Flavor(s):
FRUIT PUNCH (C73390)

NDC Code Structure

  • 45014 - Accudial Pharmaceutical, Inc.

NDC 45014-151-04

Package Description: 118 mL in 1 BOTTLE

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

NDC Product Information

Cough And Cold with NDC 45014-151 is a product labeled by Accudial Pharmaceutical, Inc.. The generic name of Cough And Cold is . The product's dosage form is and is administered via form.

Labeler Name: Accudial Pharmaceutical, Inc.

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.

  • FRUIT (UNII: C2AIY4ERZC)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

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

Labeler Name: Accudial Pharmaceutical, Inc.
Labeler Code: 45014
Start Marketing Date: 11-25-2009 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: 12-31-2017 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

Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)

Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]
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.

Cough And Cold 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

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldtemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat

Do Not Use

  • To sedate a child or to make a child sleepyif 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.

Ask A Doctor Before Use If The Child Has

  • Trouble urinating due to an enlarged prostate glandglaucomaa cough that occurs with too much phlegm (mucus)a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

When Using This Product

  • Do not use more than directedmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Directions

  • Do not take more than 4 doses in any 24-hour periodto find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by agespecifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing deviceagedoseunder 6 yearsdo not use6 to under 12 years1-2 tsp. (5-10 mL) every 6 hours

Other Information

  • Each teaspoon contains: sodium 2 mgstore at 20°-25°C (68°-77°F)

Inactive Ingredients

Artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions?

877-434-2036

* Please review the disclaimer below.