NDC 0113-2461 Good Sense Childrens Ibuprofen
Ibuprofen Tablet, Chewable Oral

Product Information

What is NDC 0113-2461?

The NDC code 0113-2461 is assigned by the FDA to the product Good Sense Childrens Ibuprofen which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Childrens Ibuprofen is ibuprofen. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-2461-62 1 bottle in 1 carton / 24 tablet, chewable 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 Code0113-2461
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 Childrens Ibuprofen
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.
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, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
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.
ANDA076359
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.
10-09-2019
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.
12-31-2023
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 Childrens Ibuprofen?


Product Characteristics

Color(s)ORANGE (C48331)
ShapeROUND (C48348)
Size(s)13 MM
Imprint(s)L461
Score2
Flavor(s)ORANGE (C73406)

Product Packages

NDC Code 0113-2461-62

Package Description: 1 BOTTLE in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE

Price per Unit: $0.13802 per EA

Product Details

What are Good Sense Childrens Ibuprofen 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.
  • IBUPROFEN 100 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.

Good Sense Childrens Ibuprofen 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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

Good Sense Childrens Ibuprofen 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 Childrens Ibuprofen 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 Ingredient (In Each Chewable Tablet)



Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever/fever reducer


Uses



temporarily:

  • •reduces fever
  • •relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Warnings



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.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child:

    • •has had stomach ulcers or bleeding problems
    • •takes a blood thinning (anticoagulant) or steroid drug
    • •takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • •takes 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.

      Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.


Do Not Use



  • •if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • •right before or after heart surgery

Ask A Doctor Before Use If



  • •stomach bleeding warning applies to your child
  • •child has a history of stomach problems, such as heartburn
  • •child has problems or serious side effects from taking pain relievers or fever reducers
  • •child has not been drinking fluids
  • •child has lost a lot of fluid due to vomiting or diarrhea
  • •child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
  • •child has asthma
  • •child is taking a diuretic

Ask A Doctor Or Pharmacist Before Use If The Child Is



  • •under a doctor’s care for any serious condition
  • •taking any other drug

When Using This Product



  • •mouth or throat burning may occur; give with food or water
  • •take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If



  • •child experiences any of the following signs of stomach bleeding:
  • •feels faint
  • •vomits blood
  • •has bloody or black stools
  • •has stomach pain that does not get better
  • •child has symptoms of heart problems or stroke:
  • •chest pain
  • •trouble breathing
  • •weakness in one part or side of body
  • •slurred speech
  • •leg swelling
  • •the child does not get any relief within first day (24 hours) of treatment
  • •fever or pain gets worse or lasts more than 3 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear

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)


Directions



  • chew or crush tablets completely before swallowing
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • •find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • •if needed, repeat dose every 6-8 hours
  • •do not use more than 4 times a day
  • Dosing Chart

    Weight (lb)

    Age (yr)

    Tablets

    under 24

    under 2

    ask a doctor

    24-35

    2-3

    1

    36-47

    4-5

    1 ½

    48-59

    6-8

    2

    60-71

    9-10

    2 ½

    72-95

    11

    3


Other Information



  • •phenylketonurics: contains phenylalanine 6 mg per tablet
  • •store between 20-25°C (68-77°F)
  • •do not use if printed seal under cap is broken or missing

Inactive Ingredients



acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid


Questions Or Comments?



1-800-719-9260


Principal Display Panel



For Ages 2 to 11 Years

Chewables

Children’s

Ibuprofen Chewable Tablets, 100mg

Pain Reliever / Fever Reducer (NSAID)

Orange Flavor

Lasts Up To 8 Hours

24 Chewable Tablets

Compare to active ingredient of Children’s Motrin®

100% SATISFACTION GUARANTEED

Chew or Crush Tablets Completely Before Swallowing


* Please review the disclaimer below.