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

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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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50844-392
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax 
Starch, Corn 
Fd&c Yellow No. 6 
Hypromellose 
Lactose 
Magnesium Stearate 
Polydextrose 
Polyethylene Glycol 
Stearic Acid 
Titanium Dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44392
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-392-021 in 1 CARTON
112 in 1 BOTTLE, PLASTIC
2NDC:50844-392-081 in 1 CARTON
224 in 1 BOTTLE, PLASTIC
3NDC:50844-392-151 in 1 CARTON
350 in 1 BOTTLE, PLASTIC
4NDC:50844-392-121 in 1 CARTON
4100 in 1 BOTTLE, PLASTIC
5NDC:50844-392-14500 in 1 BOTTLE, PLASTIC
6NDC:50844-392-161000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/02/1999
Labeler - L.N.K. International, Inc. (038154464)
Registrant - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
L.N.K. International, Inc.038154464MANUFACTURE

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.