IBUPROFEN  - ibuprofen tablet 
ASCEND LABORATORIES LLC

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Ibuprofen Tablets, USP 400mg, 600mg and 800mg

Cardiovascular Risk

Gastrointestinal Risk

DESCRIPTION




Structural Formula


CLINICAL PHARMACOLOGY


ADVERSE REACTIONS

ADVERSE REACTIONS







INDICATIONS AND USAGE


WARNINGS




CONTRAINDICATIONS



WARNINGS, Anaphylactoid Reactions, PRECAUTIONS, Preexisting Asthma

WARNINGS

WARNINGS

CARDIOVASCULAR EFFECTS

Cardiovascular Thrombotic Events

WARNINGS
CONTRAINDICATIONS

Hypertension

Congestive Heart Failure and Edema

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
prior history of peptic ulcer disease and/or gastrointestinal bleeding

Renal Effects

Advanced Renal Disease

Anaphylactoid Reactions
CONTRAINDICATIONS PRECAUTIONS, Preexisting Asthma

Skin Reactions

Pregnancy

PRECAUTIONS

General

Hepatic effects

Hematological effects






Preexisting asthma

Ophthalmological effects

Aseptic Meningitis

Information for Patients


Laboratory Tests

Drug Interactions
ACE-inhibitors:


Aspirin


Diuretics
WARNINGS, Renal Effects


Lithium




Methotrexate


Warfarin-type anticoagulants



H-2 Antagonists

Pregnancy
Teratogenic effects: Pregnancy Category C



Nonteratogenic effects


Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

ADVERSE REACTIONS






ADVERSE REACTIONS table

OVERDOSAGE




DOSAGE AND ADMINISTRATION

WARNINGS





Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:
Suggested Dosage:



CLINICAL PHARMACOLOGY

In chronic conditions
Mild to moderate pain:

Dysmenorrhea:

HOW SUPPLIED




















Ascend logo









Medication Guide
for



What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.



NSAID medicines should never be used right before or after a heart surgery called a

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.
Ulcers and bleeding:




The chance of a person getting an ulcer or bleeding increases with:








NSAID medicines should only be used:




What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?




Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:




Tell your healthcare provider:





What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include:
Other side effects include:
• heart attack
• stroke
• high blood pressure
• heart failure from body swelling (fluid retention)
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and intestine
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma

• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting
• dizziness
 
 
 

Get emergency help right away if you have any of the following symptoms:






Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:













Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)



NSAID medicines that need a prescription
Generic Name
Tradename
Celecoxib
Celebrex
Diclofenac
Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal
Dolobid
Etodolac
Lodine, Lodine XL
Fenoprofen
Nalfon, Nalfon 200
Flurbirofen
Ansaid
Ibuprofen
Motrin, Tab-Profen, *Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin
Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen
Oruvail
Ketorolac
Toradol
Mefenamic Acid
Ponstel
Meloxicam
Mobic
Nabumetone
Relafen
Naproxen
Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin
Daypro
Piroxicam
Feldene
Sulindac
Clinoril
Tolmetin
Tolectin, Tolectin DS, Tolectin 600


This Medication Guide has been approved by the U.S. Food and Drug Administration.

ASCEND
Laboratories, LLC

NDC 67877-119-05

IBUPROFEN
TABLETS, USP

400 mg

Rx Only

500 Tablets

bottle label


IBUPROFEN 
ibuprofen   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67877-119
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code IBU;400
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 67877-119-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 02/06/2009

Labeler - ASCEND LABORATORIES LLC (141250469)
Revised: 12/2009 ASCEND LABORATORIES LLC