FILM COATED IBUPROFEN- ibuprofen tablet 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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Active ingredient

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 steriod drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, napraxen, 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 heath 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
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • 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, fumes 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

HEALTHCARE

SEE NEW WARNINGS INFORMATION

NDC 64092-200-30

Ibuprofen

Compare to Active Ingredient of Advil®†

Ibuprofen Tablets USP, 200 mg

Pain Reliever and Fever Reducer (NSAID)

24 + 6 Free Tablets

HEALTHCARE GUARANTEE

If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund.

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

50844    REV0910C29101

Distributed by: Great Lakes Wholesale & Marketing L.L.C.

3729 Patterson Ave., S.E., Grand Rapids, MI 49512

291-01

FILM COATED IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;291
Contains    
Packaging
#Item CodePackage Description
1NDC:64092-200-301 in 1 CARTON
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501005/24/1988
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)

Revised: 07/2011
 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.