Your browser does not support JavaScript! IBUPROFEN TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]
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RxNorm Names

IBUPROFEN tablet, film coated
[Stephen L. LaFrance Pharmacy, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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
    • toothache
    • menstrual cramps
    • the common cold
    • backache
    • muscular aches
    • minor pain of arthritis
  • temporarily reduces fever

Warnings

 Allergy alert: Ibuprofen maay cause a severe allergic reaction, especially in people allergy to aspirin. Sympoms may include:

  • facial swelling
  • rash
  • hives
  • asthma (wheezing)
  • shock
  • skin reddening
  • 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 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
  • any new symptoms appear
  • redness or swelling is present in the painful area
  • fever gets worse or lasts more than 3 days

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.

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)
  • used by expiration date on package

Inactive ingredients

carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions

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

Principal Display Panel

select brand®
the lower price name brand

NDC 15127-905-50

IBUPROFEN
IBUPROFEN TABLETS USP, 200 mg
PAIN RELIEVER/FEVER REDUCER


†Compare to the Active Ingredient of Motrin® IB

50 Film Coated Orange Tablets

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

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Motrin® IB.
50844         REV0411B39215

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA

Select Brand 44-392

Select Brand 44-392

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15127-905
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;392
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-905-501 in 1 CARTON
150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513903/30/2002
Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-905)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-905)

Revised: 10/2012
 
Stephen L. LaFrance Pharmacy, Inc.

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