PROBUFEN- ibuprofen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

SAMSUNG PHARM IND. CO., LTD.

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 400 mg in 537 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSE: Pain reliever, Fever Reducer 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)

Authorization status:

OTC monograph not final

Summary of Product characteristics

PROBUFEN- IBUPROFEN TABLET
SAMSUNG PHARM IND. CO., LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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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