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  4. NDC Product Code: 50580-344 Extra Strength Tylenol Cold Plus Flu Multi-action Day

NDC 50580-344 Extra Strength Tylenol Cold Plus Flu Multi-action Day

Acetaminophen,Pseudoephedrine Hydrochloride,And Dextromethorphan Hydrobromide Tablet, Film - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50580-344?
  5. Extra Strength Tylenol Cold Plus Flu Multi-action Day Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
50580-344
Proprietary Name:
Extra Strength Tylenol Cold Plus Flu Multi-action Day
Non-Proprietary Name: [1]
Acetaminophen, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Johnson & Johnson Consumer Inc.
    Labeler Code:
    50580
    Product Label ID:
    7d3266dc-879a-4d28-b8ea-74d238c3020a
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    06-21-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    OVAL (C48345)
    Size(s):
    18 MM
    Imprint(s):
    TY;COLD;1408
    Score:
    1

    Product Packages

    NDC Code 50580-344-01

    Package Description: 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK

    Product Details

    What is NDC 50580-344?

    The NDC code 50580-344 is assigned by the FDA to the product Extra Strength Tylenol Cold Plus Flu Multi-action Day which is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Extra Strength Tylenol Cold Plus Flu Multi-action Day is acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 50580-344-01 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack. 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 Extra Strength Tylenol Cold Plus Flu Multi-action Day?

    Do not take more than directed (see overdose warning)adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor

    What are Extra Strength Tylenol Cold Plus Flu Multi-action Day 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 500 mg/1 - 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.
    • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 - 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.
    • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

    Which are Extra Strength Tylenol Cold Plus Flu Multi-action Day UNII Codes?

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

    Which are Extra Strength Tylenol Cold Plus Flu Multi-action Day 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 Extra Strength Tylenol Cold Plus Flu Multi-action Day?

    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: 1250743 - acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet
    • RxCUI: 1250743 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
    • RxCUI: 1250743 - APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet

    Which are the Pharmacologic Classes for Extra Strength Tylenol Cold Plus Flu Multi-action Day?

    * 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]


    Pseudoephedrine


    Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing 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.

    [2] 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.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".