IBUPROFEN - ibuprofen tablet, film coated 
L.N.K. International, Inc.

----------

Ibuprofen Tablets USP, 200 mg

DRUG FACTS

ACTIVE INGREDIENT

(in each orange tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

WARNINGS

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If 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 perscription or nonperscription 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

  • 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
    • vomit blood
    • have bloody or black stools
    • 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 right away.

DIRECTIONS

 

  • do not take 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 over: 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 INFORMATION

INACTIVE INGREDIENTS

 

carnauba wax, cellulose, corn starch, FD&C yellow #6, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodiumstarch glycolate, stearic acid, titanium dioxide

Questions or comments?

call 1-800-426-9391

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Quality Plus

Ibuprofen Tablets USP, 200 mg

Pain Reliever / Fever Reducer (NSAID)

1000 Film Coated Orange Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

primary-display
IBUPROFEN  
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-392
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax (UNII: R12CBM0EIZ)  
Starch, Corn (UNII: O8232NY3SJ)  
Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
Hypromellose (UNII: 3NXW29V3WO)  
Lactose (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
Polydextrose (UNII: VH2XOU12IE)  
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44392
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50844-392-02 1 in 1 CARTON
1 12 in 1 BOTTLE, PLASTIC
2 NDC:50844-392-08 1 in 1 CARTON
2 24 in 1 BOTTLE, PLASTIC
3 NDC:50844-392-15 1 in 1 CARTON
3 50 in 1 BOTTLE, PLASTIC
4 NDC:50844-392-12 1 in 1 CARTON
4 100 in 1 BOTTLE, PLASTIC
5 NDC:50844-392-14 500 in 1 BOTTLE, PLASTIC
6 NDC:50844-392-16 1000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075139 03/02/1999
Labeler - L.N.K. International, Inc. (038154464)
Registrant - L.N.K. International, Inc. (038154464)
Establishment
Name Address ID/FEI Business Operations
L.N.K. International, Inc. 038154464 MANUFACTURE

Revised: 12/2009
Document Id: ce9466d7-2e5f-adfb-3d89-f61d7196b950
Set id: 027ded51-aa01-6619-3938-c8162a421cf3
Version: 1
Effective Time: 20091215
 
L.N.K. International, Inc.