NDC 0113-5300 Good Sense Dual Action
Acetaminophen, Ibuprofen Tablet, Film Coated Oral

Product Information

What is NDC 0113-5300?

The NDC code 0113-5300 is assigned by the FDA to the product Good Sense Dual Action which is a human over the counter drug product labeled by L Perrigo Company. The generic name of Good Sense Dual Action is acetaminophen, ibuprofen. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0113-5300-16 1 bottle in 1 carton / 144 tablet, film coated in 1 bottle, 0113-5300-68 1 bottle in 1 carton / 36 tablet, film coated 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 Code0113-5300
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.		Good Sense Dual Action
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, Ibuprofen
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; Ibuprofen
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 FormTablet, 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) 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.		L Perrigo Company
Labeler Code0113
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.		ANDA214836
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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.		03-01-2023
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 Good Sense Dual Action?


Product Characteristics

Color(s)YELLOW (C48330)
ShapeOVAL (C48345)
Size(s)14 MM
Imprint(s)I;I
Score1

Product Packages

NDC Code 0113-5300-16

Package Description: 1 BOTTLE in 1 CARTON / 144 TABLET, FILM COATED in 1 BOTTLE

NDC Code 0113-5300-68

Package Description: 1 BOTTLE in 1 CARTON / 36 TABLET, FILM COATED in 1 BOTTLE

Product Details

What are Good Sense Dual Action 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 nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.

Good Sense Dual Action 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:

Good Sense Dual Action 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.

Good Sense Dual Action 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



Active Ingredients (In Each Caplet)



Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever


Uses



  • •temporarily relieves minor aches and pains due to:
  • •headache
  • •toothache
  • •backache
  • •menstrual cramps
  • •muscular aches
  • •minor pain of arthritis

Warnings



Acetaminophen liver damage warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • •with other drugs containing acetaminophen
  • •more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • •3 or more alcoholic drinks every day while using this product

    • Acetaminophen allergy alert: may cause severe skin reactions.

    Symptoms may include:

    • •skin reddening
    • •blisters
    • •rash

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

      NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to

      aspirin.

      Symptoms may include:

      • •hives
      • •facial swelling
      • •asthma (wheezing)
      • •shock
      • •skin reddening
      • •rash
      • •blisters

        • If an allergic reaction occurs, stop use and seek medical help right away.

        NSAID stomach bleeding warning:

        This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if

        you:

        • •are age 60 or older
        • •have had stomach ulcers or bleeding problems
        • •take a blood thinning (anticoagulant) or steroid drug
        • •take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
        • •have 3 or more alcoholic drinks every day while using this product
        • •take more or for a longer time than directed

          • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.


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
  • •if you have ever had an allergic reaction to acetaminophen or any other pain reliever
  • •right before or after heart surgery

Ask A Doctor Before Use If



  • •you have liver disease
  • •stomach bleeding warning applies to you
  • •you have problems or serious side effects from taking pain relievers
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • •you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are



  • •under a doctor’s care for any serious condition
  • •taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • •taking any other drug

When Using This Product



  • •take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If



  • •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have stomach pain that does not get better
  • •you have symptoms of heart problems or stroke:
  • •chest pain
  • •trouble breathing
  • •weakness in one part or side of body
  • •slurred speech
  • •leg swelling
  • •pain gets worse or lasts more than 10 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear

If Pregnant Or Breast-Feeding,



ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Keep Out Of Reach Of Children.



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


Directions



  • •do not take more than directed

    • Adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist

    Children under 12 years: ask a doctor

    • •do not take more than 6 caplets in 24 hours, unless directed by a doctor

Other Information



  • •read all warnings and directions before use. Keep carton.
  • •store at 20-25°C (68-77°F)
  • •avoid excessive heat above 40°C (104°F)

Inactive Ingredients



colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



GOODSENSE®

Acetaminophen plus Ibuprofen

CONTAINS 2 MEDICINES

Dual Action

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144 Caplets**

**Capsule-Shaped Tablets

Compare to active ingredients of Advil® Dual Action

dual action-image 1 - image 01

dual action-image 1 - image 01


* Please review the disclaimer below.