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  4. NDC Product Code: 0573-0147 Advil Dual Action With Acetaminophen

NDC 0573-0147 Advil Dual Action With Acetaminophen

Ibuprofen,Acetaminophen Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0573-0147?
  5. Advil Dual Action With Acetaminophen 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:
0573-0147
Proprietary Name:
Advil Dual Action With Acetaminophen
Non-Proprietary Name: [1]
Ibuprofen, Acetaminophen
Substance Name: [2]
Acetaminophen; Ibuprofen
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]
    Haleon Us Holdings Llc
    Labeler Code:
    0573
    Product Label ID:
    f5ea858e-76d9-4777-b3dc-5d614f66d485
    FDA Application Number: [6]
    NDA211733
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-27-2020
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Shape:
    OVAL (C48345)
    Size(s):
    15 MM
    Imprint(s):
    ADVIL;II
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0573-0147?

    The NDC code 0573-0147 is assigned by the FDA to the product Advil Dual Action With Acetaminophen which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Advil Dual Action With Acetaminophen is ibuprofen, acetaminophen. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 8 packages with assigned NDC codes 0573-0147-09 8 tablet, film coated in 1 bottle , 0573-0147-18 1 bottle in 1 carton / 18 tablet, film coated in 1 bottle, 0573-0147-36 1 bottle in 1 carton / 36 tablet, film coated in 1 bottle, 0573-0147-72 1 bottle in 1 carton / 72 tablet, film coated in 1 bottle, 0573-0147-86 1 bottle in 1 carton / 216 tablet, film coated in 1 bottle, 0573-0147-91 3000 pouch in 1 case / 2 tablet, film coated in 1 pouch, 0573-0147-94 1 bottle in 1 carton / 144 tablet, film coated in 1 bottle, 0573-0147-95 50 pouch in 1 carton / 2 tablet, film coated in 1 pouch. 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 Advil Dual Action With Acetaminophen?

    Usestemporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsmuscular achesminor pain of arthritis

    What are Advil Dual Action With Acetaminophen 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 250 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.
    • IBUPROFEN 125 mg/1 - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties

    Which are Advil Dual Action With Acetaminophen UNII Codes?

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

    Which are Advil Dual Action With Acetaminophen 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 Advil Dual Action With Acetaminophen?

    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:

    Which are the Pharmacologic Classes for Advil Dual Action With Acetaminophen?

    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.

    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]


    Ibuprofen


    Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
    [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".