IBUPROFEN- ibuprofen tablet 
Medline industries, Inc.

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DRUG FACTS

Active ingredient

Ibuprofen USP, 200 mg (NSAID)*

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*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
minor pain of arthritis
backache
menstrual cramps
muscular aches
toothache
the common cold
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
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 problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if

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
vomit blood
have bloody or black stools
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 (1-800-222-1222)

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 at 20-25°C (68-77°F)

Inactive Ingredients  

Carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide

Questions

Questions or comments?

Call Toll Free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm CST

Principal Display Panel

Medline

NDC 53329-677-30

+Compare to the active ingredient in Advil Tablets

Ibuprofen Tablets USP

Pain Reliever/

Fever Reducer (NSAID)

200 mg

100 coated tablets - 200 mg each

Ibuprofen Tablets PDP and drug facts
IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-677
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-677-301 in 1 CARTON
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07646004/21/2015
Labeler - Medline industries, Inc. (025460908)

Revised: 5/2015
Document Id: 15821573-03c8-490f-9295-74430aa07dfe
Set id: 15821573-03c8-490f-9295-74430aa07dfe
Version: 1
Effective Time: 20150501
 
Medline industries, Inc.