NDC 68599-8050 Ibuprofen

Ibuprofen Tablets

NDC Product Code 68599-8050

NDC CODE: 68599-8050

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 Tablets 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 for the short-term treatment of mild to moderate pain in adults. When used with a narcotic (such as morphine) it may be used to treat moderate to severe pain. It is also used to reduce fever. This medication is a nonsteroidal anti-inflammatory drug (NSAID).

Product Characteristics

Color(s):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;291

NDC Code Structure

NDC 68599-8050-4

Package Description: .2 g in 1 PACKET

NDC Product Information

Ibuprofen with NDC 68599-8050 is a a human over the counter drug product labeled by Mckesson. The generic name of Ibuprofen is ibuprofen tablets. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Mckesson

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

  • IBUPROFEN .2 g/g

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.

  • POVIDONE K30 (UNII: U725QWY32X)
  • TALC (UNII: 7SEV7J4R1U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • 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.
  • 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: Mckesson
Labeler Code: 68599
FDA Application Number: ANDA075010 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 01-31-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* 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

Other

Drug Facts

Otc - Active Ingredient

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

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

  • UsesTemporarily relieves minor aches and pains associated withheadachetoothachebackachemenstrual crampscommon coldmuscular achesminor arthritis painTemporarily reduces fever.

Warnings

  • WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • Hivesskin reddeningasthma (wheezing)acial swellingrashshockblistersIf 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 or 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 - Stop Use

  • Do not useif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgeryAsk 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 diureticAsk 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 When using this producttake with food or milk if stomach upset occursStop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faintvomit blood have bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or strokechest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts for more than 10 daysfever gets worse or lasts for more than 3 daysredness or swelling is present in the painful areaany new or unexpected symptoms occurIf 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 specifically 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.

Dosage & Administration

  • Directionsdo not use more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings)Adults and children: (12 years and older)
  • Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
  • Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
  • Children under 12 years:
  • Do not give to children under 12 years of age.

Other Safety Information

  • Other informationread all product information before usingstore at 68-77°F (20-25°C)avoid excessive heat 40°C (above 104°F)tamper evident sealed packetsdo not use any opened or torn packets

Inactive Ingredient

Inactive ingredients
carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*,

polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

Otc - Questions

Questions? 1-800-777-4908

* Please review the disclaimer below.