Your browser does not support JavaScript! MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

MOTRIN IB (ibuprofen) tablet, film coated
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


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

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)1


1
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 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets 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 no. 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

NDC 50580-110-38

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

300 Coated Caplets*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL
MOTRIN IB 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-110
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 
ferrosoferric oxide 
magnesium stearate 
polydextrose 
polyethylene glycols 
propylene glycol 
shellac 
stearic acid 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize16mm
FlavorImprint Code Motrin;IB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-110-011 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:50580-110-021 in 1 CARTON
250 in 1 BOTTLE, PLASTIC
3NDC:50580-110-031 in 1 CARTON
324 in 1 BOTTLE, PLASTIC
4NDC:50580-110-071 in 1 CARTON
450 in 1 BOTTLE
5NDC:50580-110-091 in 1 CARTON
5165 in 1 BOTTLE, PLASTIC
6NDC:50580-110-101 in 1 CARTON
6100 in 1 BOTTLE, PLASTIC
7NDC:50580-110-192 in 1 POUCH
8NDC:50580-110-371 in 1 CARTON
8300 in 1 BOTTLE, PLASTIC
9NDC:50580-110-381 in 1 CARTON
9300 in 1 BOTTLE, PLASTIC
10NDC:50580-110-511 in 1 CARTON
10500 in 1 BOTTLE, PLASTIC
11NDC:50580-110-5250 in 1 TRAY
11NDC:50580-110-192 in 1 POUCH
12NDC:50580-110-601 in 1 CARTON
1260 in 1 BOTTLE, PLASTIC
13NDC:50580-110-62225 in 1 BOTTLE, PLASTIC
14NDC:50580-110-641 in 1 CARTON
1430 in 1 BOTTLE, PLASTIC
15NDC:50580-110-751 in 1 CARTON
15150 in 1 BOTTLE, PLASTIC
16NDC:50580-110-761 in 1 CARTON
1675 in 1 BOTTLE, PLASTIC
17NDC:50580-110-951 in 1 CARTON
17125 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01901208/01/2000
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 3/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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