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:
L.N.K. International, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis - headache - toothache - backache - menstrual cramps - the common cold - muscular aches - minor pain of arthritis - temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
50844-292-00, 50844-292-01, 50844-292-02, 50844-292-08, 50844-292-11, 50844-292-12, 50844-292-13, 50844-292-14, 50844-292-15, 50844-292-16

IBUPROFEN- ibuprofen tablet, film coated

L.N.K. International, Inc.

----------

Ibuprofen Tablets USP, 200 mg

Active Ingredient (in each brown caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache

toothache

backache

menstrual cramps

the common cold

muscular aches

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:

hives

facial swelling

asthma (wheezing)

skin reddening

shock

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

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

right before or after heart surgery

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you

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

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

weakness in one part or side of body

trouble breathing

slurred speech

leg swelling

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

any new symptoms appear

redness or swelling is present in the painful area

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 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)

avoid excessive heat 40°C (104°F)

use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium

stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch

glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

Quality

+ Plus

NDC 50844-292-16

†Compare to active ingredient

in Advil® Caplets

IBUPROFEN TABLETS

USP, 200 mg

PAIN RELIEVER/

FEVER REDUCER (NSAID)

1000 Coated Caplets

ACTUAL

SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Wyeth Consumer

Healthcare, owner of the registered trademark Advil® Caplets.

50844 REV1116B29216

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

Quality Plus 4 4 -292 REV1116

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 44-29 2

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

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)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

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

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

OVAL

S iz e

14mm

Flavor

Imprint Code

44;29 2

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

1

12 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

2

24 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

3

30 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

4

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

4

50 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

5

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

5

6 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

6

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

6

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

7

NDC:50 8 44-29 2-

1 in 1 CARTON

0 5/24/19 8 8

7

250 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

8

NDC:50 8 44-29 2-

250 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/24/19 8 8

9

NDC:50 8 44-29 2-

50 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/24/19 8 8

10

NDC:50 8 44-29 2-

10 0 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/24/19 8 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 750 10

0 5/24/19 8 8

Labeler -

L.N.K. International, Inc. (038154464)

Establishment

L.N.K. International, Inc.

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(50 8 44-29 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(50 8 44-29 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(50 8 44-29 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(50 8 44-29 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(50 8 44-29 2)

Revised: 4/2020

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