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Ibuprofen by Cardinal Health

Medically reviewed on April 4, 2018

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: Cardinal Health
NDC Code: 70000-0291

Leader 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:

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

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • 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)
  • see end flap for expiration date and lot number

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?

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

Principal display panel

LEADER

NDC 7000-0291-1

Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

Color Free
& Dye Free

100 TABLETS

ACTUAL SIZE

COMPARE TO
MOTRIN® IB

active ingredient†

100% Money Back Guarantee

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

CIN 5331681    REV. 4/17

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

50844     ORG111643812

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

100% Money Back Guarantee
Return to place of purchase if not satisfied.

CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

Leader 44-438

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0291
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TRIACETIN 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;438
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0291-11 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70000-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(70000-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0291)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(70000-0291)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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