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

----------

Quality Plus 44-291

Active ingredient (in each brown 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:

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

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

  • 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, 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
    • weakness in one part or side of body
    • leg swelling
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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

Other information

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

Principal Display Panel

Quality
+
Plus

NDC 50844-291-16

Compare to active ingredient
in Advil® Tablets

IBUPROFEN TABLETS
USP, 200 mg

PAIN RELIEVER/
FEVER REDUCER (NSAID)

1000 Coated Tablets

ACTUAL
SIZE

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

This product is not manufactured or distributed by PF Consumer
Healthcare 1 LLC, owner of the registered trademark Advil® Tablets.
50844           REV1221C29116

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

Quality Plus 44-291

Quality Plus 44-291

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-291
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-291-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
2NDC:50844-291-021 in 1 CARTON05/24/1988
212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:50844-291-081 in 1 CARTON05/24/1988
324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:50844-291-011 in 1 CARTON05/24/1988
430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:50844-291-101 in 1 CARTON05/24/1988
540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:50844-291-151 in 1 CARTON05/24/1988
650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:50844-291-111 in 1 CARTON05/24/1988
760 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:50844-291-121 in 1 CARTON05/24/1988
8100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC:50844-291-291 in 1 CARTON05/24/1988
9150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10NDC:50844-291-131 in 1 CARTON05/24/1988
10250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11NDC:50844-291-99250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
12NDC:50844-291-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
13NDC:50844-291-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
14NDC:50844-291-17300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/1988
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(50844-291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(50844-291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(50844-291) , pack(50844-291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(50844-291)

Revised: 8/2023
Document Id: fc931971-3bcb-46b4-b6f9-4bd163154f1a
Set id: 57b39311-bc20-ace6-75a9-a07a9311b373
Version: 19
Effective Time: 20230807
 
L.N.K. International, Inc.