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Ibuprofen by COSTCO WHOLESALE CORPORATION

Medically reviewed on October 12, 2017

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg
Labeler: COSTCO WHOLESALE CORPORATION
NDC Code: 63981-393

Kirkland 44-393

Active ingredient (in each orange caplet)

 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:

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

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

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

Ask a doctor or pharmacist before use if you are
  • taking any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition

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 caplet every 4 to 6 hours while symptoms persist 

  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • use by expiration date on package
  • store between 20º-25ºC (68º-77ºF)
  • avoid excessive heat 40ºC (104ºF)

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 1-800-426-9391 8:30 a.m.-4:00 p.m. ET, Monday-Friday

Principal Display Panel

KIRKLAND
Signature

NDC 63981-393-14
ITM./ART. 808083

COMPARE TO MOTRIN® IB active ingredient**

IBUPROFEN
IB TABLETS
Ibuprofen Tablets USP, 200 mg

Pain Reliever
Fever Reducer
(NSAID)

500
Caplets†
†capsule-shaped 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 Johnson & Johnson Corporation, owner of the registered trademark Motrin® IB.

This product does not contain gluten

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For: Costco Wholesale Corporation
P.O. Box 34535, Seattle, WA 98124-1535 USA
1-800-774-2678    www.costco.com

50844    REV0616B39314

Kirkland 44-393


IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-393
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
POLYDEXTROSE 
STEARIC ACID 
TITANIUM DIOXIDE 
LACTOSE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;393
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-393-14500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:63981-393-58750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/01/1999
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63981-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63981-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63981-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63981-393)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63981-393)

 
COSTCO WHOLESALE CORPORATION

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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