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:
Pharbest Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Reliever/ Fever Reducer - temporarily relieves minor aches and pain 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, or asthma - 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 - pain gets worse or lasts mo
Authorization status:
Abbreviated New Drug Application
Authorization number:
16103-407-06, 16103-407-08, 16103-407-11

IBUPROFEN- ibuprofen tablet, film coated

Pharbest Pharmaceuticals, Inc.

----------

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti- inflammatory drug

Purpos e

Pain Reliever/ Fever Reducer

Us es

temporarily relieves minor aches and pain 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

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, or asthma

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

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.

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

Do not take more than directed

The smallest effective dose should be used

adults and

children 12

years of age

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

and over

exceed 6 tablets in 24 hours unless directed by a doctor

children under

12 years

consult a doctor

Other information

Tamper Evident: do not use if safety seal under cap is broken or missing

store at room temperature (20 - 25 C)

avoid excessive heat above 40 C (104 F)

Inactive ingredients

carnuba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium

stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, stearic acid,

sodium starch glycolate, titanium dioxide

Questions or comments?

(866) 562-2756 Mon-Fri: 8 AM to 4 PM

PHARBEST

NDC 16103-407-11

*Compare to the active ingredient in ADVIL

Pain Reliever/Fever Reducer (NSAID)

Ibuprofen

Tablets

200 mg

1000 Tablets

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:16 10 3-40 7

®

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)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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

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

PO LYDEXTRO SE (UNII: VH2XOU12IE)

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

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

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

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

44;29 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:16 10 3-40 7-

1 in 1 CARTON

10 /0 1/20 18

1

50 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:16 10 3-40 7-

1 in 1 CARTON

10 /0 1/20 18

2

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:16 10 3-40 7-

10 0 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Pharbest Pharmaceuticals, Inc.

ANDA

ANDA0 750 10

10 /0 1/20 18

Labeler -

Pharbest Pharmaceuticals, Inc. (557054835)

Registrant -

Pharbest Pharmaceuticals, Inc. (557054835)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharbest Pharmaceuticals, Inc.

5570 548 35

relabel(16 10 3-40 7) , repack(16 10 3-40 7)

Revised: 10/2018

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