IBUPROFEN tablet, film coated

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: - the common cold - headache - menstrual cramps - toothache - muscular aches - backache - minor pain of arthritis - temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
0904-7914-51, 0904-7914-59, 0904-7914-61, 0904-7914-80

IBUPROFEN- ibuprofen tablet, film coated

Major Pharmaceuticals

----------

Major 44-438-delisted

Active ingredient (in each white tablet)

Ibuprofen USP,

200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

the common cold

headache

menstrual cramps

toothache

muscular aches

backache

minor pain of arthritis

temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

skin reddening

rash

facial swelling

asthma (wheezing)

hives

shock

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

take a blood thinning (anticoagulant) or steroid drug

are age 60 or older

have had stomach ulcers or bleeding problems

have 3 or more alcoholic drinks every day while using this product

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen,

or others]

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 any other pain reliever/fever reducer

right before or after heart surgery

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you are taking a diuretic

you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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

have bloody or black stools

vomit blood

have stomach pain that does not get better

you have symptoms of heart problems or stroke:

chest pain

slurred speech

leg swelling

trouble breathing

weakness in one part or side of body

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 (1-800-222-1222) right away.

Directions

do not take more than directed

the smallest effective dose should be used

adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist

if pain or fever does not respond to 1 tablet, 2 tablets may be used

do not exceed 6 tablets 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)

avoid excessive heat 40°C (104°F)

see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate,

microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate,

stearic acid, triacetin

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR

NDC 0904-7914-51

Compare to the active ingredient

in Motrin IB Tablets

IBU-200

Ibuprofen Tablets USP, 200 mg

PAIN RELIEVER

FEVER REDUCER (NSAID)

50 Tablets

Dye-Free Film Coated Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered

trademark Motrin IB Tablets. 50844 REV0418B43815

Distributed by: MAJOR PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152 USA M-17 Rev. 07/18

Re-order No. 700808

®

4 4 - 4 38

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-79 14

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)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYDEXTRO SE (UNII: VH2XOU12IE)

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

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRIACETIN (UNII: XHX3C3X6 73)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

44;438

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:0 9 0 4-79 14-6 1 10 in 1 CARTON

0 3/0 1/19 9 9

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 9 0 4-79 14-59

1 in 1 CARTON

0 3/0 1/19 9 9

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 9 0 4-79 14-51

1 in 1 CARTON

0 3/0 1/19 9 9

3

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 9 0 4-79 14-

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/19 9 9

11/26 /20 21

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 75139

0 3/0 1/19 9 9

Labeler -

Major Pharmaceuticals (191427277)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Major Pharmaceuticals

LNK Internatio nal, Inc.

0 38 15446 4

PACK(0 9 0 4-79 14)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(0 9 0 4-79 14)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(0 9 0 4-79 14)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(0 9 0 4-79 14)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(0 9 0 4-79 14)

Revised: 3/2020

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