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.
Otc - Active Ingredient
Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*)*nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducer
Indications & Usage
Usestemporarily relieves minor aches and pains due to:■ headache ■ toothache ■ backache ■ menstrual cramps■ common cold ■ muscular aches ■ minor arthritis paintemporarily 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 ■ blistersIf 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 directedHeart 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.
Otc - Do Not Use
Do not use■ if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer■ right before or after heart surgery
Otc - Ask Doctor
Ask a doctor before use if■ 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are■ 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
Otc - When Using
When using this product■ take with food or milk if stomach upset occurs
Otc - Stop Use
Stop use and ask a doctor if■ 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 symptoms appear
Otc - Pregnancy Or Breast Feeding
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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
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:■ ask a doctor
Other Safety Information
Other information■ store at 68-77°F (20-25°C)■ avoid excessive heat 104°F (above 40°C)■
TAMPER EVIDENT child resistant packets
■ do not use any opened or torn packets
Inactive ingredientscarnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone k-30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide*may contain
Otc - Questions
Questions or comments? 1-800-634-7680
* Please review the disclaimer below.