PROBUFEN: Package Insert and Label Information

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.

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

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of blister pack
(click image for full-size original)

PROBUFEN ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49789-050
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg in 537 mg
Inactive Ingredients
Ingredient Name Strength
lactose
magnesium stearate
Talc
Methylene Chloride
Product Characteristics
Color orange Score no score
Shape OVAL Size 15mm
Flavor Imprint Code SSP4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49789-050-01 537 mg in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/01/2011
Labeler — SAMSUNG PHARM IND. CO., LTD. (687744425)
Registrant — SAMSUNG PHARM IND. CO., LTD. (687744425)
Establishment
Name Address ID/FEI Operations
SAMSUNG PHARM IND. CO., LTD. 687744425 manufacture (49789-050)

Revised: 09/2012 SAMSUNG PHARM IND. CO., LTD.

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