Active Ingredient
Ibuprofen 200 mg (NSAID)
*nonsteroidal antinflamatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Tender Corporation for the product Easy Care First Aid Ibuprofen (NDC 44224-0018). 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, purpose, uses, allergy alert:, stomach bleeding warning:, heart attack or stroke warning:, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)
*nonsteroidal antinflamatory drug
Pain reliever/fever reducer
Temporarily relieves minor aches and pains associated with
■ headache ■ toothache ■ backache ■ menstrual cramps
■ common cold ■ muscular aches ■ minor arthritis pain
Temporarily reduces fever
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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
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.
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ 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
■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
■ under a doctor’s care for any serious condition
■ taking any other drug
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more than directed or longer than directed
■ 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 ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ redness or swelling is present in the painful area
■ any new or unexpected symptoms occur
In case of overdose, get medical help or contact a Poison Control Center right away.
■ do not use more than directed
■ the smallest effective dose should be used
■ do 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.
■ read all product information before using
■ store at 68-77°F (20-25°C)
■ avoid excessive heat 40°C (above 104°F)
■ tamper evident sealed packets
■ do not use any opened or torn packets
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
2 Tablets
See Card for Complete Product Information
* Please review the disclaimer below.