MOTRIN IB- ibuprofen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
JC World Bell Wholesale Co., Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
• 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
50269-000-25

MOTRIN IB- ibuprofen tablet

JC World Bell Wholesale Co., Inc.

----------

MOTRIN IB 25's

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:

MOTRIN IB

ibuprofen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 26 9 -0 0 0

JC World Bell Wholesale Co., Inc.

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

OVAL

S iz e

14mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 26 9 -0 0 0 -25

25 in 1 BOX

12/10 /20 18

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77349

12/10 /20 18

Labeler -

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

Revised: 3/2019

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