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

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LNK 44-438

Active ingredient (in each white tablet)

 Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever

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:

  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • take other drugs containing prescription or nonprescription 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers 

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

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
  • chest pain
  • slurred speech
  • leg swelling 
  • trouble breathing
  • weakness in one part or side of body
  • 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 (1-800-222-1222) right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • 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

  • store between 20º-25ºC (68º-77ºF)
  • avoid excessive heat 40ºC (104ºF)
  • use by expiration date on package 

Inactive ingredients

corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin 

Questions or comments?

1-800-426-9391

B and B

BB 44-438

BB 44-438


CVS Health 

CVS Health 44-438

CVS Health 44-438


Equate

Equate 44-438

Equate 44-438


Leader 

Leader 44-438

Leader 44-438


Major

Major 44-438

Major 44-438


Walgreens 

Walgreens 44-438

Walgreens 44-438


IBUPROFEN  DYE FREE
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;438
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-852-082 in 1 CASE03/01/1999
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50844-852-8810 in 1 CARTON03/01/1999
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50844-852-121 in 1 CARTON03/01/1999
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50844-852-151 in 1 CARTON03/01/1999
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:50844-852-371 in 1 CARTON03/01/1999
575 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:50844-852-161000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
7NDC:50844-852-8950 in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACTANDA07513903/01/1999
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(50844-852)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(50844-852)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(50844-852)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(50844-852)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(50844-852)

Revised: 1/2018
 
L.N.K. International, Inc.