IBUPROFEN- ibuprofen 200mg tablet, film coated

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

Buy It Now

Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
ADVANCED FIRST AID, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
pain reliever/fever reducer Uses: temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces fever
Authorization status:
Abbreviated New Drug Application
Authorization number:
67060-002-67, 67060-002-68

IBUPROFEN- ibuprofen 200mg tablet, film coated

ADVANCED FIRST AID, INC.

----------

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)

*nonsteroidal anti-inflammatory drug

pain reliever/fever reducer

Uses:

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain

of arthritis toothache menstrual cramps common cold 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 blisters If an allergic reaction

occurs, stop use and seek medical help right away.

Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause 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 non prescription 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: 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 heart burn 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: pain gets worse or lasts more than 10 days fever gets worse or lasts

more than 3 days or if redness or swelling is present in the painful area any new symptoms appear

You experience any of the following signs of stomach bleeding: feel faint vomit blood or 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 the body slurred

speach leg swelling

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 specifically 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 :

Adults and children 12 years of age and older:

do not take more than directed the smallest effective dose should be used 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 of age: ask a doctor

Inactive Ingredients: croscarmellose sodium*, FD& C Blue #2*, FD& C Red #40*, FD& C Yellow

#6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*,

medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*,

polyvinyl alcohol*, Povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*,

talc*, titanium dioxide, triacetin*.

*contains one or mored of these ingredients

IBUPROFEN

ibuprofen 200mg tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 70 6 0 -0 0 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

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

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

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 70 6 0 -0 0 2-6 8

10 0 in 1 CARTON

0 3/20 /20 19

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 70 6 0 -0 0 2-6 7

250 in 1 CARTON

0 3/20 /20 19

2

2 in 1 PACKET; 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 9 1239

0 3/20 /20 19

ADVANCED FIRST AID, INC.

Labeler -

ADVANCED FIRST AID, INC. (114477180)

Registrant -

ADVANCED FIRST AID, INC. (114477180)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ULTRA SEAL CORPORATION

0 8 57520 0 4

pa c k(6 70 6 0 -0 0 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Marksans Pharma

9 258 229 75

ma nufa c ture (6 70 6 0 -0 0 2)

Revised: 3/2019

Similar products

Search alerts related to this product

View documents history

Share this information