NDC 59779-438 Ibuprofen Dye Free

Ibuprofen

  1. Labeler Index
  2. Cvs Pharmacy
  3. NDC: 59779-438 Ibuprofen Dye Free

NDC Product Code 59779-438

NDC CODE: 59779-438

Proprietary Name: Ibuprofen Dye Free 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 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;438
Score: 1

NDC Code Structure

NDC 59779-438-12

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

NDC 59779-438-15

Package Description: 50 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Ibuprofen Dye Free with NDC 59779-438 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Ibuprofen Dye Free is ibuprofen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Cvs Pharmacy

Dosage Form: Tablet, 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.

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 Dye Free 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 200 mg/1

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.
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TRIACETIN (UNII: XHX3C3X673)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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: Cvs Pharmacy
Labeler Code: 59779
FDA Application Number: ANDA075139 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: 03-01-1999 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’.

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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 Dye Free Product Label Images

Ibuprofen Dye Free 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 White Tablet)

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

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:muscular aches backache toothachemenstrual crampsheadachethe common cold minor pain of arthritistemporarily reduces fever

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.Symptoms may include:rashfacial swellingasthma (wheezing) hivesskin reddeningshockblistersIf 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:take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problemshave 3 or more alcoholic drinks every day while using this productare age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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

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

Ask A Doctor Before Use If

  • Stomach 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 diureticyou have problems or serious side effects from taking pain relievers or fever reducers

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 aspirintaking 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 fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betteryou have symptoms of heart problems or strokechest painslurred speechleg swelling trouble breathingweakness in one part or side of bodypain 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

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 (1-800-222-1222) right away.

Directions

  • Do not take more than directedthe smallest effective dose should be usedadults and children 12 years and over: take 1 tablet every 4 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 years: ask a doctor

Other Information

  • Store between 20º-25ºC (68º-77ºF)avoid excessive heat 40ºC (104ºF)use by expiration date on package

Inactive Ingredients

Corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

* Please review the disclaimer below.