IBUPROFEN TABLETS USP 200 mg

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
One2Zee Limited Liability Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever / fever reducer ■    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
Authorization status:
Abbreviated New Drug Application
Authorization number:
55629-095-01

IBUPROFEN- ibuprofen tablet

One2Zee Limited Liability Company

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IBUPROFEN TABLETS USP 200 mg

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID)*

____________________________________

* nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever / fever reducer

INDICATIONS AND USAGE

■ 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

WARNINGS

Allergy alert

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

Symptoms may include:

hives

facial swelling

rash

blisters

shock

skin reddening

asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a non-steroidal anti-inflammatory drug (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

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

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, or kidney disease

you have asthma

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

the risk of heart attack or stroke may increase if you use more than directed or for longer than

directed

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

■ 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.

OTC - 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.

DOSAGE AND ADMINISTRATION

do not take more than directed

the smallest effective dose should be used

adults and children

12 years and older

■ 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

STORAGE AND HANDLING

■ Store between 20-25°C (68-77°F)

tamper evident: do not use if imprinted safety seal under cap is broken or missing;

do not use if seal is open or missing in bulk pack.

INACTIVE INGREDIENT

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose,

pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc

OTC - QUESTIONS

Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM

SPL UNCLASSIFIED

Manufactured by:

Strides Pharma Science Limited

Puducherry - 605014, India

See New Warnings Information

Ibuprofen Tablets USP 200 mg

Pain Reliever / Fever Reducer (NSAID)

- 30000 coated tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN

ibuprofen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:556 29 -0 9 5

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SE 2 2 0 8 ( 10 0 MPA.S) (UNII: B1QE5P712K)

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

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

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

TALC (UNII: 7SEV7J4R1U)

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

One2Zee Limited Liability Company

Product Characteristics

Color

BROWN

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

IBU20 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:556 29 -0 9 5-0 1

1 in 1 BOX

0 4/0 2/20 19

1

30 0 0 0 in 1 BAG; 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 79 129

0 4/0 2/20 19

Labeler -

One2Zee Limited Liability Company (078656111)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Strides Pharma Science Limited

8 7140 2375

ANALYSIS(556 29 -0 9 5) , MANUFACTURE(556 29 -0 9 5) , PACK(556 29 -0 9 5)

Revised: 4/2019

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