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

----------

Quality Plus 44-744-Delisted

Active ingredient (in each tablet)

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


Purpose

Pain reliever/fever reducer


Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • menstrual cramps
  • toothache
  • backache
  • minor arthritis pain
  • the common cold
  • muscular aches

Temporarily reduces fever.

Warnings

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

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

  • 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

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present in the painful area
  • any new or unexpected symptoms occur

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 specifically 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 use 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

  • read all product information before using
  • store at 68 ̊-77 ̊F (20 ̊-25 ̊C)
  • avoid excessive heat 104 ̊F (above 40 ̊C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain


Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET,

Monday-Friday


Principal display panel

NDC 50844-269-24

QUALITY PLUS

†Compare to active ingredient in Advil® Tablets

IBUPROFEN
TABLETS, 200 mg

PAIN RELIEVER/
FEVER REDUCER (NSAID)

60 Packets of 2 Tablets each
200 mg each

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF PACKET IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Advil® Tablets.

50844 ORG

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

44-744

44-744

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-269
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (reddish brown) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code G;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-269-2460 in 1 CARTON11/18/201906/07/2024
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917411/18/201906/07/2024
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(50844-269)

Revised: 6/2024
Document Id: c08e5c55-c1fb-4143-ac18-938f0b634bc5
Set id: 36e682c2-37d4-4f76-acfd-99dd13a3f6ab
Version: 6
Effective Time: 20240617
 
L.N.K. International, Inc.