MOTRIN IB- ibuprofen tablet, film coated

Motrin IB by

Drug Labeling and Warnings

Motrin IB by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MOTRIN IB 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Motrin;IB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-110-01	1 in 1 CARTON	08/01/2000	04/05/2015
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 50580-110-02	1 in 1 CARTON	08/01/2000	06/23/2017
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 50580-110-07	1 in 1 CARTON	04/16/2013	06/23/2017
3		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 50580-110-09	1 in 1 CARTON	08/01/2000	04/30/2013
4		165 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 50580-110-10	1 in 1 CARTON	08/01/2000	06/23/2017
5		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 50580-110-19	2 in 1 POUCH; Type 0: Not a Combination Product	08/01/2000
7	NDC: 50580-110-38	1 in 1 CARTON	08/01/2000	06/23/2017
7		300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 50580-110-51	1 in 1 CARTON	08/01/2000	12/31/2018
8		500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9	NDC: 50580-110-52	50 in 1 TRAY	08/01/2000
9	NDC: 50580-110-19	2 in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 50580-110-60	1 in 1 CARTON	08/01/2000	01/01/2019
10		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11	NDC: 50580-110-62	225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2000	06/23/2017
12	NDC: 50580-110-75	1 in 1 CARTON	08/01/2000
12		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13	NDC: 50580-110-76	1 in 1 CARTON	08/01/2000
13		75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14	NDC: 50580-110-95	1 in 1 CARTON	08/01/2000
14		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019012	08/01/2000

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)