MOTRIN IB- ibuprofen tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Motrin® IB

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 packet is opened

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 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-110-52

Motrin® IB

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

Convenient
Take-Along
Packs

Coated Caplets*

*Capsule-Shaped Tablets

Convenient
Take-Along
Packs

50 Pouches of 2 Coated Caplets* Each
*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL
MOTRIN IB 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-110
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)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
starch, corn (UNII: O8232NY3SJ)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
ferrosoferric oxide (UNII: XM0M87F357)  
magnesium stearate (UNII: 70097M6I30)  
polydextrose (UNII: VH2XOU12IE)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
shellac (UNII: 46N107B71O)  
stearic acid (UNII: 4ELV7Z65AP)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize16mm
FlavorImprint Code Motrin;IB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-110-011 in 1 CARTON08/01/200004/05/2015
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:50580-110-021 in 1 CARTON08/01/200006/23/2017
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:50580-110-071 in 1 CARTON04/16/201306/23/2017
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:50580-110-091 in 1 CARTON08/01/200004/30/2013
4165 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:50580-110-101 in 1 CARTON08/01/200006/23/2017
5100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:50580-110-192 in 1 POUCH; Type 0: Not a Combination Product08/01/200011/30/2019
7NDC:50580-110-381 in 1 CARTON08/01/200006/23/2017
7300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:50580-110-511 in 1 CARTON08/01/200012/31/2018
8500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC:50580-110-5250 in 1 TRAY08/01/200011/30/2019
9NDC:50580-110-192 in 1 POUCH; Type 0: Not a Combination Product
10NDC:50580-110-601 in 1 CARTON08/01/200001/01/2019
1060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11NDC:50580-110-62225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/200006/23/2017
12NDC:50580-110-751 in 1 CARTON08/01/200010/25/2013
12150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13NDC:50580-110-761 in 1 CARTON08/01/200010/25/2013
1375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14NDC:50580-110-951 in 1 CARTON08/01/200010/25/2013
14125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01901208/01/200011/30/2019
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 4/2020
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division