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:
COSTCO WHOLESALE CORPORATION
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: - backache - menstrual cramps - toothache - headache - the common cold - muscular aches - minor pain of arthritis - temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
63981-291-03, 63981-291-14

IBUPROFEN- ibuprofen tablet, film coated

COSTCO WHOLESALE CORPORATION

----------

Kirkland 44-291

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

backache

menstrual cramps

toothache

headache

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:

facial swelling

shock

asthma (wheezing)

skin reddening

hives

blisters

rash

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 more or for a longer time than directed

are age 60 or older

take a blood thinning (anticoagulant) or steroid drug

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

or others]

have had stomach ulcers or bleeding problems

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

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

you are taking a diuretic

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 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

use by expiration date on package

store between 20°-25°C (68°-77°F)

avoid excessive heat 40°C (104°F)

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

KIRKLAND

Signature

COMPARE TO

ADVIL

active ingredient**

NDC 63981-291-14

ITM. / ART. 808082

IBUPROFEN

Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Actual Size

500

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

**This product is not manufactured or distributed

by PF Consumer Healthcare 1 LLC, owner of the

registered trademark Advil® .

This product does not contain gluten.

Manufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535 USA

1-800-774-2678 www.costco.com 20V09017a

50844 REV0618D29114

®

Kirkland 4 4 -291

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 8 1-29 1

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)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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

PO LYDEXTRO SE (UNII: VH2XOU12IE)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

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

ROUND

S iz e

10 mm

Flavor

Imprint Code

44;29 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 39 8 1-29 1-

1 in 1 PACKAGE

0 5/24/19 8 8

1

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

2

NDC:6 39 8 1-29 1-

50 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 -

COST CO WHOLESALE CORPORAT ION (103391843)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(6 39 8 1-29 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(6 39 8 1-29 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(6 39 8 1-29 1)

COSTCO WHOLESALE CORPORATION

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(6 39 8 1-29 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(6 39 8 1-29 1)

Revised: 6/2020

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