IBUPROFEN- ibuprofen tablet, film coated 
CARDINAL HEALTH

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Leader 44-291-Delisted

Active ingredient (in each brown 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
    • backache
    • toothache
    • 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 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 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

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

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
    • have bloody or black stools
    • vomit blood
    • 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
  • 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)
  • see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, 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

NDC 37205-670-85

LEADER®

Compare to Advil® active ingredient†

Ibuprofen
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)

Film Coated Brown Tablets

250 TABLETS

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

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Tablets.

50844        REV0411A29113

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4556858    www.myleader.com   
1-800-200-6313

All Leader®  Brand products are 100% satisfaction guaranteed or return to place of purchase for full refund.
Leader 44-291

Leader 44-291


IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-670
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (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)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-670-901 in 1 CARTON05/24/198807/25/2019
1500 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:37205-670-851 in 1 CARTON05/24/198807/14/2020
2250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/198807/14/2020
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37205-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(37205-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(37205-670)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(37205-670)

Revised: 11/2020
 
CARDINAL HEALTH