IBUPROFEN- ibuprofen tablet 
Medline Industries

----------

DRUG FACTS

Active Ingredient (in each 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
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
    • 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 an seek medical help right away.

Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance are higher if you:

  • are age 60 or oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.

Do not use

  • if you ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the 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 have asthma
  • you are taking a diuretic.

Ask a doctor or pharmacist before use if you are

  • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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 bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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 older
  •  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- 25o C (68o- 77o F)

Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions or comments?

Call toll free 1-800-MEDLINE (633-5463) Monday- Friday 9AM-5PM CST

Principal Display Panel

†Compare to the active ingredient in ADVIL®

Ibuprofen Tablets USP    

Pain Reliever/ Fever Reducer (NSAID)*

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

DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING

READ ALL WARNINGS AND DIRECTIONS BEFORE USE. KEEP CARTON.

PRODUCT OF INDIA

Distributed by:

Medline Industries, Inc.

One Medline Place

Mundelein, IL 60060

Product Label

Medline Industries

Ibuprofen Tablets

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-673
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-673-301 in 1 BOX01/15/201312/29/2023
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917401/15/201312/29/2023
Labeler - Medline Industries (025460908)
Registrant - P & L Development, LLC (079765031)

Revised: 12/2021
Document Id: f683cca6-3747-4ac8-9165-f34d4147bb97
Set id: 8a0aa98e-cd07-44fe-ba4c-ef3af4066c68
Version: 4
Effective Time: 20211207
 
Medline Industries