Active Ingredient (In Each White Tablet)
Ibuprofen USP, 200 mg (NSAID)*
The following Structured Product Label (SPL) was submitted to the FDA by Breeden Brothers, Llc for the product Dye Free Ibuprofen (NDC 70729-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen USP, 200 mg (NSAID)*
Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
_ temporarily relieves minor aches and pains due to:
_ backache _ muscular aches _ minor pain of arthritis
_ headache _ menstrual cramps
_ toothache _ the common cold
_ temporarily reduces fever
Drug Facts (continued)
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
_ hives _ facial swelling _ asthma (wheezing)
_ shock _ skin reddening _ rash _ blisters
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:
_ are age 60 or older
_ have had stomach ulcers or bleeding problems
_ take a blood thinning (anticoagulant) or steroid drug
_ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
_ have 3 or more alcoholic drinks every day while using this product
_ take more or for a longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
Drug Facts (continued)
These can be fatal. The risk is higher if you use more than directed or for longer than directed.
_ if you have ever had an allergic reaction to any other pain reliever/fever reducer
_ right before or after heart surgery
_ 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
_ under a doctor's care for any serious condition
_ taking any other drug
Drug Facts (continued)
_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
_ take with food or milk if stomach upset occurs
_ you 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 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
_ any new symptoms appear
_ redness or swelling is present in the painful area
Drug Facts (continued)
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
_ 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
Drug Facts (continued)
_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
_ store between 20°-25°C (68°-77°F)
_ avoid excessive heat 40°C (104°F)
_ use by expiration date on package
corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
1-800-901-2420
Dist. by Breeden Brothers, LLC
Nashville, TN 37219
* Please review the disclaimer below.