IBUPROFEN- ibuprofen tablet, film coated 
Topco Associates, LLC

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TopCare 44-393

Active ingredient (in each orange caplet)

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

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

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
    • weakness in one part or side of body
    • leg swelling
    • trouble breathing
    • slurred speech
  • 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 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, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-888-423-0139

Principal Display Panel

+TopCare®
health

NDC 36800-993-06

COMPARE TO MOTRIN® IB CAPLETS
ACTIVE INGREDIENT

Ibuprofen
Tablets USP, 200 mg

• PAIN RELIEVER
• FEVER REDUCER 
(NSAID)

200 CAPLETS

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
topcare@topco.com  www.topcarebrand.com
Visit here for more information: http://topbrnds.com/48ZZSN

This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Motrin® IB Caplets.
50844             REV1221C39306

TopCare 44-393

TopCare 44-393

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-993
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize14mm
FlavorImprint Code 44;393
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-993-06200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(36800-993)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(36800-993)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(36800-993)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(36800-993)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(36800-993)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(36800-993)

Revised: 11/2023
Document Id: 1909045f-8a59-47d3-844c-a49fa61ca541
Set id: bcf7d4c1-1f99-48df-8f74-9abeefa8d41d
Version: 12
Effective Time: 20231108
 
Topco Associates, LLC