FDA Label for Probufen
View Indications, Usage & Precautions
Probufen Product Label
The following document was submitted to the FDA by the labeler of this product Samsung Pharm Ind. Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
ACTIVE INGREDIENT: Ibuprophen 400mg
Inactive Ingredient
Inactive ingredients:
lactose, microcrystalline cellulose, magnesium stearate, Light Anhydrous Silicic Acid, titanium oxide, Talc, tar colorant, Hypromellose2910, Polyethylene Glycol, Ethanol, Methylene Chloride
Purpose
PURPOSE: Pain reliever, Fever Reducer
Dosage And Administration
Direction
1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, psoriatic arthritis:
200-600mg per dosage orally, 3~4 times a day as ibuprofen for adults.
Maximum dosage is 3200mg per day.
2. Juvenile rheumatoid arthiritis:
30-40mg per kg of body weight divided into 3~4 portions per day orally.
3. Mild and moderate pain, common cold:
200-400mg per dosage orally, 3~4 times a day for adults.
Appropriately increase or reduce dosage by age or symptom.
4. Children should take the unit-dose below, 3~4 times a day orally.
The dosage of children weighing less than 30kg should not exceed 500mg per day.
It is advisable to avoid administering on an empty stomach.
Unit-dose for children:
11 - 14 yrs : 200 - 250 mg
7 - 10 yrs : 150 - 200 mg
3 - 6 yrs : 100 - 150 mg
1 - 2 yrs : 50 - 100 mg
Indications And Usage
Uses
1. Major effects
Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain.
2. This can be used also for the following diseases.
Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumatism (tendinitis, tendosynovitis, synovitis)
Warnings
WARNING
1. When those who drink alcohol over three glasses every day regularly with to take this drug or other antipyretic and analgesic, they must consult a doctor or pharmacist. Gastrointestinal bleeding may occur when these people take this drug.
2. Cardiovascular risks: Administering non-steroidal anti-inflammatory drugs (NSAIDs) including this product may lead to severe cardiovascular thrombotic response, myocardial infaction, and stroke. The possibility of abnormal cardiovascular reaction increases in patients with a period. Adverse reactions should be carefully monitored while an adverse reaction occurs.
3. Gastrointestinal risk: Administering NSAIDs including this product may cause severe gastrointestinal adverse reactions that may develop without any warning signs during the administration period. The risk of these adverse reactions increases in old age (elderly people) or in patients who have taken this drug for a long period.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Storage And Handling Section
Other informations:
Store in a hemetic container.
Store between 1C to 30C
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