NDC 59779-438 Ibuprofen Dye Free
Tablet, Film Coated Oral
Product Information
What is NDC 59779-438?
The NDC code 59779-438 is assigned by the FDA to the product Ibuprofen Dye Free which is a human over the counter drug product labeled by Cvs Pharmacy. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 59779-438-12 1 bottle, plastic in 1 carton / 100 tablet, film coated in 1 bottle, plastic, 59779-438-15 50 tablet, film coated in 1 bottle, plastic . 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.
What are the uses for Ibuprofen Dye Free?
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) | WHITE (C48325) |
Shape | ROUND (C48348) |
Size(s) | 10 MM |
Imprint(s) | 44;438 |
Score | 1 |
Product Packages
NDC Code 59779-438-12
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC Code 59779-438-15
Package Description: 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Details
What are Ibuprofen Dye Free Active Ingredients?
- IBUPROFEN 200 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.
Ibuprofen Dye Free Active Ingredients UNII Codes
- IBUPROFEN (UNII: WK2XYI10QM)
- IBUPROFEN (UNII: WK2XYI10QM) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 310965 - ibuprofen 200 MG Oral Tablet
- RxCUI: 310965 - ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet
Ibuprofen Dye Free Inactive Ingredients UNII Codes
- 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)
Pharmacologic Class(es)
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Patient Education
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
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 WHITE TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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
- toothache
- menstrual cramps
- headache
- the common cold
- minor pain of arthritis
- temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
- rash
- facial swelling
- asthma (wheezing)
- hives
- skin reddening
- shock
- blisters
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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 you:
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 surgery
- if 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 you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you 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 condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking 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 faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness 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 (1-800-222-1222) right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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: ask a doctor
Other Information
- store between 20°-25°C (68°-77°F)
- avoid excessive heat 40°C (104°F)
- 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
Questions Or Comments?
Call 1-800-426-9391 8:30 AM - 4:00 PM ET, Monday-Friday
Principal Display Panel
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Compare to the active ingredient in Advil® Tablets†
Coated Tablets
NDC 59779-438-15
DYE FREE
Ibuprofen
IBUPROFEN TABLETS USP, 200 mg
Pain reliever, Fever reducer (NSAID)
50 COATED TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil® Tablets.
50844 REV1116A43815
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