IBUPROFEN capsule, liquid filled

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
BJWC
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 - temporarily reduces fever - if you have ever had an allergic reaction to any other pain reliever/fever reducer - right before or after heart surgery - 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 - 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 - 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 sym
Authorization status:
Abbreviated New Drug Application
Authorization number:
68391-212-83

IBUPROFEN- ibuprofen capsule, liquid filled

BJWC

----------

Drug Facts

Active ingredient (in each capsule)

Solubilized ibuprofen equal to

200 mg ibuprofen (NSAID)

(present as the free acid and potassium salt)

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)

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 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 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 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

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

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.

Directions

do not take more than directed

the smallest effective dose should be used

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

if pain or fever does not respond to 1 capsule, 2 capsules may be used

do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

Other information

each capsule contains: potassium 20 mg

read all warnings and directions before use

store at 20° to 25°C (68° to 77°F)

avoid excessive heat above 40°C (104°F). Protect from light.

Inactive ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water,

sorbitan and sorbitol

Questions or comments?

call toll free 1-800-934-1204

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH

“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

*All trademarks are property of their respective owners. This product is not affiliated with the

makers/owners of Advil

LIQUI-GELS .

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Distributed by:

BJ’s Wholesale Club

25 Research Drive

Westborough, MA 01581

Questions? 1-800-934-1204

Rev # 03/19

BJ # 228163

L0000235

300's Bottle Label

Compare to the active ingredient in Advil

LIQUI-GELS

berkley jensen

IBUPROFEN CAPSULES, 200mg

®

PAIN RELIEVER/FEVER REDUCER (NSAID)

Actual Size

300 SOFTGELS**

**LIQUID FILLED CAPSULES

Front

Back

IBUPROFEN

ibuprofen capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 39 1-212

Route of Administration

ORAL

Active Ingredient/Active Moiety

BJWC

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

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

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

blue

S core

no sco re

S hap e

c a psule

S iz e

20 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 39 1-212-8 3

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 6 8 2

0 8 /14/20 19

Labeler -

BJWC (159082692)

Registrant -

Bionpharma Inc. (079637826)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Patheo n So ftgels Inc.

0 0 219 38 29

ma nufa c ture (6 8 39 1-212)

Revised: 9/2019

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