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Ibuprofen by Aurohealth LLC

Medically reviewed on November 10, 2017

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Aurohealth LLC
NDC Code: 58602-802

Ibuprofen Tablets

Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses
  • 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
  • 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

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 ibuprofen or 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, 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
  • 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
  • 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

Other information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. 
  • see top panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call 1-855-274-4122
 

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


Code No.: TS/DRUGS/22/2009
Made in India



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle)

NDC 58602-802-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)

NDC 58602-802-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Tablets
AUROHEALTH

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-802
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSE 2910 (6 MPA.S) 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 400 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (Light Orange to Orange) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeN;II
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-802-071 BOTTLE in 1 CARTON
124 TABLET in 1 BOTTLE
2NDC:58602-802-141 BOTTLE in 1 CARTON
250 TABLET in 1 BOTTLE
3NDC:58602-802-211 BOTTLE in 1 CARTON
3100 TABLET in 1 BOTTLE
4NDC:58602-802-291 BOTTLE in 1 CARTON
4150 TABLET in 1 BOTTLE
5NDC:58602-802-34200 TABLET in 1 BOTTLE
6NDC:58602-802-38300 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20886511/08/2017
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(58602-802), MANUFACTURE(58602-802)

 
Aurohealth LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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