IBUPROFEN- 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:
Publix Super Markets Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
56062-647-71, 56062-647-78, 56062-647-85

IBUPROFEN- ibuprofen tablet, film coated

Publix Super Markets Inc

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Publix Super Markets, Inc. Ibuprofen Caplets Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever/fever reducer

Us es

Warnings

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

Symptoms may include:

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

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

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

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,

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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.

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

right before or after heart surgery

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

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

take with food or milk if stomach upset occurs

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

children under 12 years

Other information

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron

oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium

dioxide

Principal Display Panel

ibuprofen caplets**

IBUPROFEN TABLETS, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

ACTUAL SIZE

100 COATED CAPLETS**

**CAPSULE-SHAPED TABLETS

Compare to Advil® active ingredient

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

ask a doctor

read all warnings and directions before use

store at 68-77°F (20-25°C)

avoid high humidity and excessive heat above 104°F (40°C)

see end panel for lot number and expiration date

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-6 47

Route of Administration

ORAL

Publix Super Markets Inc

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:56 0 6 2-6 47-71

1 in 1 CARTON

0 1/31/20 0 2

1

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

2

NDC:56 0 6 2-6 47-78

1 in 1 CARTON

0 9 /15/19 8 8

2

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

3

NDC:56 0 6 2-6 47-8 5

1 in 1 CARTON

0 3/20 /20 0 0

3

250 in 1 BOTTLE; 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 720 9 6

0 9 /15/19 8 8

Labeler -

Publix Super Markets Inc (006922009)

Revised: 3/2019

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