NDC 0363-7920 Walgreens Childrens Cold Plus Cough Plus Runny Nose
Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide Suspension Or...

Product Information

What is NDC 0363-7920?

The NDC code 0363-7920 is assigned by the FDA to the product Walgreens Childrens Cold Plus Cough Plus Runny Nose which is a human over the counter drug product labeled by Walgreens Co.. The generic name of Walgreens Childrens Cold Plus Cough Plus Runny Nose is acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0363-7920-04 1 bottle in 1 carton / 120 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, RxNorm crosswalk and the complete product label.

NDC Product Code0363-7920
Proprietary Name 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.		Walgreens Childrens Cold Plus Cough Plus Runny Nose
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.		Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Product Type 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.		Human Otc Drug
Dosage FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.		Walgreens Co.
Labeler Code0363
FDA Application Number 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.		part341
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-24-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Walgreens Childrens Cold Plus Cough Plus Runny Nose?


Product Characteristics

Color(s)PURPLE (C48327)
Flavor(s)GRAPE (C73391)

Product Packages

NDC Code 0363-7920-04

Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

Product Details

What are Walgreens Childrens Cold Plus Cough Plus Runny Nose Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 160 mg/5mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • CHLORPHENIRAMINE MALEATE 1 mg/5mL - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Walgreens Childrens Cold Plus Cough Plus Runny Nose Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
  • RxCUI: 1086750 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
  • RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
  • RxCUI: 1086750 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension

Walgreens Childrens Cold Plus Cough Plus Runny Nose 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Walgreens Childrens Cold Plus Cough Plus Runny Nose Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

  • ▪skin reddening
  • ▪blisters
  • ▪rash

    • If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Otc - Purpose



Active ingredients (in each 5 mL)Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Chlorpheniramine maleate 1 mg

Antihistamine

Dextromethorphan HBr 5 mg

Cough suppressant


Uses



  • ▪temporarily relieves the following cold/flu symptoms:
    • ▪minor aches and pains
    • ▪headache
    • ▪sore throat
    • ▪sneezing and runny nose
    • ▪cough
    • ▪temporarily reduces fever

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if your child takes

  • ▪more than 5 doses in 24 hours, which is the maximum daily amount
  • ▪with other drugs containing acetaminophen

Do Not Use



  • ▪with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • ▪to make a child sleepy
  • ▪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.
  • ▪if your child has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If Your Child Has



  • ▪liver disease
  • ▪a breathing problem such as chronic bronchitis
  • ▪glaucoma
  • ▪persistent or chronic cough such as occurs with asthma
  • ▪cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If Your Child Is



  • ▪taking the blood thinning drug warfarin
  • ▪taking sedatives or tranquilizers

When Using This Product



  • ▪do not exceed recommended dose (see overdose warning)
  • ▪marked drowsiness may occur
  • ▪sedatives and tranquilizers may increase drowsiness
  • ▪excitability may occur, especially in children

Stop Use And Ask A Doctor If



  • ▪pain or cough gets worse or lasts more than 5 days
  • ▪fever gets worse or lasts more than 3 days
  • ▪new symptoms occur
  • ▪redness or swelling is present
  • ▪cough comes back or occurs with rash or headache that lasts

    • These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • ▪this product does not contain directions or complete warnings for adult use
  • ▪do not give more than directed (see overdose warning)
  • ▪shake well before using
  • ▪mL = milliliter
  • ▪find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • ▪remove the child protective cap and squeeze your child's dose into the dosing cup
  • ▪repeat dose every 4 hours, while symptoms last
  • ▪do not give more than 5 times in 24 hours
    • Weight (lb)Age (yr)Dose (mL)

    under 36

    under 4 years

    do not use

    36-47

    4 to 5 years

    do not use unless directed by a doctor

    48-95

    6 to 11 years

    10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • •each 5 mL contains: sodium 3 mg
  • •store at room temperature

    • TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING


Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum


Questions Or Comments?



1-866-467-2748


Principal Display Panel



Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Runny Nose*

NDC 0363-7920-04

Children'sCold + Cough +
Runny Nose Relief

Acetaminophen - Pain Reliever-Fever Reducer

Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant

Oral Suspension

Ages 6-11 Years

  • •Fever
  • •Sore Throat
  • •Sneezing
  • •Runny Nose
  • •Cough

    • Grape Flavor

    Naturally and Artificially Flavored

    4 FL OZ (120 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAT UNDER CAP IS TORN OR MISSING.

    Distributed by:

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Cold + Cough + Runny Nose.

    WAG Childrens Cold plus Cough Plus Runny Nose Relief - childrens 01

    WAG Childrens Cold plus Cough Plus Runny Nose Relief - childrens 01


* Please review the disclaimer below.