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  4. NDC Product Code: 63824-218 Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time

NDC 63824-218 Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time

Acetaminophen,Dextromethorphan Hydrobromide,Diphenhydramine Hydrochloride,Guaifenesin,And - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63824-218?
  5. Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
63824-218
Proprietary Name:
Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, And Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Rb Health (us) Llc
Labeler Code:
63824
Product Label ID:
9aca1a68-893c-4770-8a48-d5d678058253
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
07-01-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
BLUE (C48333)
Flavor(s):
CHERRY (C73375)
BERRY (C73365)

Product Packages

NDC Code 63824-218-22

Package Description: 1 KIT in 1 CARTON * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE

Product Details

What is NDC 63824-218?

The NDC code 63824-218 is assigned by the FDA to the product Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time which is a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time is acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63824-218-22 1 kit in 1 carton * 118 ml in 1 bottle * 118 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time?

Do not give more than 6 doses in any 24-hour periodmeasure only with dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorAge (year)Dose (mL)children 6 to under 12 years of age5 mL – 10 mL every 4 hourschildren 4 to under 6 years of age2.5 mL – 5 mL every 4 hourschildren under 4 years of agedo not use this product does not contain directions or complete warnings for adult usedo not give more than directed (see Overdose warning)measure only with the dosing cup provideddo not use dosing cup with other productsdose as follows or as directed by a doctorchildren 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; not to exceed 5 doses in any 24-hour periodchildren under 6 years of age: do not use

Which are Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Childrens Delsym Cough Plus Chest Congestion Dm And Delsym Cough Plus Cold Night Time?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution
  • RxCUI: 1020138 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution
  • RxCUI: 1020138 - dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 1375932 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution

* Please review the disclaimer below.

Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]


Dextromethorphan


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 the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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Guaifenesin


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 class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
[Learn More]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".