Motrin IB

Dosage form: tablet, film coated
Ingredients: Ibuprofen 200mg
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-109

Motrin® IB

Important

Read all product information before using. Keep this box for important information.

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 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 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
  • 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 for 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 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 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 20-25°C (68-77°F)
  • do not use if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, iron oxide, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-109-04

Motrin®IB

Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Coated Tablets

MOTRIN   IB
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
silicon dioxide 
starch, corn 
FD&C yellow NO. 6 
hypromelloses 
ferric oxide red 
magnesium stearate 
polydextrose 
polyethylene glycol 
propylene glycol 
shellac 
stearic acid 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeMotrin;IB
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-109-021 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
124 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
2NDC:50580-109-031 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
250 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
3NDC:50580-109-041 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
3100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
4NDC:50580-109-111 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
4165 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
5NDC:50580-109-291 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
5125 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
6NDC:50580-109-651 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
665 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
7NDC:50580-109-751 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
7150 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
8NDC:50580-109-761 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
875 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01901202/01/2005
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 11/2010
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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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