MOTRIN IB- ibuprofen tablet

MOTRIN IB by

Drug Labeling and Warnings

MOTRIN IB by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)

*nonsteroidal anti-inflammatory drug

Purposes

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 chances are 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

 if you have ever had an allergic reaction to ibuprofen or 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, kidney disease, asthma, or had a stroke

 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

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 

 you have symptoms of heart problems or stroke: 

 chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling

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

read all warnings and directions before use

 store at 20-25°C (68-77°F)

 avoid high humidity and excessive heat above 40°C (104°F)

 do not use if pouch is torn or damaged

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

Package Labeling:

INGREDIENTS AND APPEARANCE

MOTRIN IB 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50269-000
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	MOT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50269-000-25	25 in 1 BOX	12/10/2018
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077349	12/10/2018

Labeler - JC World Bell Wholesale Co., Inc. (805257581)