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.
Active Ingredient (In Each Capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
- Temporarily relieves minor aches and pains due to:
- Muscular aches
- Minor pain of arthritis
- The common cold
- Menstrual cramps temporarily reduces fever
- Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hives
- Facial swelling
- Asthma (wheezing)
- Skin reddening
- 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 directed
Do Not Use
- If you have ever had an allergic reaction to any other pain reliever/fever reducer
- Right before or after heart surgery
Ask A Doctor Before Use If
- The stomach bleeding warning applies to you
- You have problems or serious side effects from taking pain relievers or fever reducers
- You have a history of stomach problems, such as heartburn
- You have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
- You are taking a diuretic
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
- The risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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 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.
- Do not take more than directedthe smallest effective dose should be usedadults and children 12 years and over:
- Take 1 capsule every 4 to 6 hours while symptoms persist
- If pain or fever does not respond to 1 capsule, 2 capsules may be used
- Do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
- Each capsule contains: potassium 20 mg read all warnings and directions before use.
- Store at 20° to 25°C (68° to 77°F)
- Avoid excessive heat above 40°C (104°F). Protect from light.
FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Leader Ibuprofen Softgels 200mg
* Please review the disclaimer below.