IBUPROFEN

Main information

  • Trade name:
  • IBUPROFEN - ibuprofen tablet, film coated
  • Composition:
  • IBUPROFEN 200 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IBUPROFEN  - ibuprofen tablet, film coated
    United States
  • Language:
  • English

Therapeutic information

  • 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 - headache - toothache - backache - menstrual cramps - the common cold - muscular aches - minor pain of arthritis - Temporarily reduces fever

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 63629-1467-0, 63629-1467-1, 63629-1467-2, 63629-1467-3, 63629-1467-4, 63629-1467-5, 63629-1467-6, 63629-1467-7, 63629-1467-8, 63629-1467-9
  • Last update:
  • 25-05-2019

Summary of Product characteristics: dosage, interactions, side effects

IBUPROFEN - ibuprofen tablet, film coated

Bryant Ranch Prepack

----------

IBU Tablets

Active ingredient (in each brown tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever/fever reducer

Us es

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:

shock

hives

facial swelling

asthma (wheezing)

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

the 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

redness or swelling is present in the painful area

fever gets worse or lasts more than 3 days

any new symptoms occur

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 use more than directed

the smallest effective dose should be used

do not take longer than 10 days, unless directed by a doctor (see Warnings)

adults and children 12 years and over: 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 take more than 6 tablets in 24 hours unless directed by a doctor

children under 12 years: ask a doctor

Other information

store at controlled room temperature

avoid excessive heat 40°C (104°F)

Inactive ingredients

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate,

polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

Call 1-800-540-3765

Ibuprofen 200mg Tablet

IBUPROFEN

ibuprofen tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -146 7(NDC:578 9 6 -9 41)

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)

STARCH, CO RN (UNII: O8 232NY3SJ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE (UNII: J2B2A4N9 8 G)

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

Bryant Ranch Prepack

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

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO LS (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

4429 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -146 7-1

20 in 1 BOTTLE

2

NDC:6 36 29 -146 7-2

15 in 1 BOTTLE

3

NDC:6 36 29 -146 7-3

30 in 1 BOTTLE

4

NDC:6 36 29 -146 7-4

10 0 in 1 BOTTLE

5

NDC:6 36 29 -146 7-5

6 0 in 1 BOTTLE

6

NDC:6 36 29 -146 7-6

50 in 1 BOTTLE

7

NDC:6 36 29 -146 7-7

40 in 1 BOTTLE

8

NDC:6 36 29 -146 7-8

10 in 1 BOTTLE

9

NDC:6 36 29 -146 7-9

56 in 1 BOTTLE

10

NDC:6 36 29 -146 7-0

9 0 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 750 10

0 1/0 1/20 0 4

Labeler -

Bryant Ranch Prepack (171714327)

Registrant -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -146 7) , RELABEL(6 36 29 -146 7)

Revised: 7/2014