Ibuprofen (Page 4 of 4)

HOW SUPPLIED

Ibuprofen tablets are available in the following strengths :
400 mg (White to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side)
Bottles of 100 (NDC 67877-294-01)
Bottles of 500 (NDC 67877-294-05)
600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side)
Bottles of 30 (NDC 67877-295-30)
Bottles of 50 (NDC 67877-295-50)
Bottles of 100 (NDC 67877-295-01)
Bottles of 500 (NDC 67877-295-05)
800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side)
Bottles of 30 (NDC 67877-296-30)
Bottles of 50 (NDC 67877-296-50)
Bottles of 100 (NDC 67877-296-01)
Bottles of 500 (NDC 67877-296-05)
Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature]
Rx only
Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645
Manufactured by:
Marksans Pharma Ltd.
Verna, Goa-403 722, India
Rev. 07/13

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
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. This chance increases:
• with longer use of NSAID medicines
• in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
• can happen without warning symptoms
• may cause death
The chance of a person getting an ulcer or bleeding increases with:
• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health
NSAID medicines should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
• different types of arthritis
• menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery
Tell your healthcare provider:
• about all your medical conditions
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor. 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:
• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands and feet
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.NSAID medicines that need a prescription

*
Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
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

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 and/or to Ascend Laaboratories at 1-877-272-7901.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revision: R306/09
Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645
Manufactured by:
Marksans Pharma Ltd. Verna, Goa-403 722, India

Ibuprofen600mg
(click image for full-size original)
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33358-187(NDC:67877-295)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (White to off white) Score no score
Shape CAPSULE (capsule shaped, biconvex) Size 18mm
Flavor Imprint Code 122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33358-187-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:33358-187-60 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:33358-187-15 15 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 11/09/2014
Labeler — RxChange Co. (781126805)
Establishment
Name Address ID/FEI Operations
RxChange Co. 781126805 repack (33358-187)

Revised: 11/2014 RxChange Co.

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