NDC 63868-771 Childrens Mucus And Cough Relief

NDC Product Code 63868-771

NDC CODE: 63868-771

Proprietary Name: Childrens Mucus And Cough Relief 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)
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 63868 - Chain Drug Manufacturing Assn

NDC 63868-771-04

Package Description: 1 BOTTLE in 1 CARTON > 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

Childrens Mucus And Cough Relief with NDC 63868-771 is a product labeled by Chain Drug Manufacturing Assn. The generic name of Childrens Mucus And Cough Relief is . The product's dosage form is and is administered via form.

Labeler Name: Chain Drug Manufacturing Assn

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

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

Labeler Name: Chain Drug Manufacturing Assn
Labeler Code: 63868
Start Marketing Date: 10-19-2015 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: 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]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]

* Please review the disclaimer below.

Childrens Mucus And Cough Relief 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

Otc - Purpose

Active ingredients (in each 5 mL)PurposesDextromethorphan HBr 5 mgCough suppressantGuaifenesin 100 mgExpectorant

Uses

  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive •temporarily relieves: •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants •the intensity of coughing •the impulse to cough to help your child get to sleep

Otc - Do Not Use

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Otc - Ask Doctor

  • Ask a doctor before use if the child has •cough that occurs with too much phlegm (mucus) •persistent or chronic cough such as occurs with asthma

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 at 1-800-222-1222.

Directions

  • •do not take more than 6 doses in any 24-hour period •measure only with dosing cup provided •do not use dosing cup with other products •mL = milliliterAgeDosechildren 6 years to under 12 years5 mL – 10 mL every 4 hourschildren 4 years to under 6 years2.5 mL – 5 mL every 4 hourschildren under 4 yearsdo not use

Other Information

  • •each 5 mL contains: sodium 3 mg •Tamper -evident: do not use if printed inner seal under cap is torn or missing •store at room temperature •do not refrigerate •dosing cup provided

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

* Please review the disclaimer below.