NDC 54868-0984 Ibuprofen

NDC Product Code 54868-0984

NDC CODE: 54868-0984

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.

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: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
2I
Score: 1

NDC Code Structure

NDC 54868-0984-0

Package Description: 50 TABLET in 1 BOTTLE, PLASTIC

NDC 54868-0984-3

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

NDC 54868-0984-4

Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ibuprofen with NDC 54868-0984 is a product labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 310965.

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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 10-16-2007 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
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)...
[Read More]

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Ibuprofen Product Label Images

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

Active Ingredient (In Each Tablet)

Ibuprofen 200 mg (NSAID)**nonsteroidal anti- inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

  • Temporarily relieves minor aches and pain due tominor pain of arthritisheadachetoothachebackachethe common coldmenstrual crampsmuscular achestemporarily reduces fever

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may includehivesfacial swelling asthma (wheezing)shockskin reddeningrashblistersIf 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthmayou are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

  • Take food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding feel faint vomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or last for more than 10 days fever gets worse or last more than 3 daysredness 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 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.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away.This package is not for households with young children.

Directions

  • Do not take more than directed the smallest effective dose should be usedAdults and children 12 years and oldertake 1 tablet every4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 yearsask a doctor

Other Information

  • Store between 20o- 25oC (68o- 77oF)avoid high humidity and excessive heat above 40oC (104oF)

Inactive Ingredients:

Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DC yellow# 10, FDC blue# 2, FDC red# 40, FDC yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide

Questions? Adverse Drug Event Call: (800)687-0176

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark ADVIL®.

* Please review the disclaimer below.