NDC 41226-600 Ibuprofen

Ibuprofen

NDC Product Code 41226-600

NDC CODE: 41226-600

Proprietary Name: Ibuprofen 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.

Non-Proprietary Name: Ibuprofen 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
117
Score: 1

NDC Code Structure

NDC 41226-600-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE

NDC 41226-600-42

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE

NDC 41226-600-50

Package Description: 500 TABLET, COATED in 1 BOTTLE

NDC Product Information

Ibuprofen with NDC 41226-600 is a a human over the counter drug product labeled by Kroger Company. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 310965.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug 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.

Ibuprofen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Labeler Name: Kroger Company
Labeler Code: 41226
FDA Application Number: part343 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 06-12-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Ibuprofen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose
Pain reliever/Fever reducer

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:backache
  • Headache
  • Menstrual cramps
  • Minor pain of arthritis
  • Muscular aches
  • The common cold
  • Toothache
  • Temporarily reduces fever

Warnings

  • WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
  • Symptoms may include:
  • Asthma (wheezing)blistersfacial swellinghivesrashshockskin reddeningIf 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 you:
  • Are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood-thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedHeart 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.

Otc - Do Not Use

  • Do not useif you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducerright before or after heart surgery

Otc - Ask Doctor

  • Ask a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diuretic

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor’s care for any serious conditiontaking any other drug

Otc - When Using

  • When using this producttake with food or milk if stomach upset occurs

Otc - Stop Use

  • Stop use and ask a doctor ifyou 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 problem or stroke:chest pain
  • Trouble breathing
  • Weakness in one part or side of the body
  • Slurred speech
  • Leg swelling
  • Pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

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).

Dosage & Administration

  • Directionsdo not take more than directedthe smallest effective dose should be usedadults and children 12 years and over:take 1 caplet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 caplet, 2 caplets may be useddo not exceed 6 caplets in 24 hours, unless directed by a doctorchildren under12 years:ask a doctor

Other Information

  • Other informationread all warnings and directions before usestore at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Otc - Questions

Questions or comments? Call 1-800-632-6900

* Please review the disclaimer below.