Ibuprofen (Page 5 of 5)

Mild to moderate pain:

400 mg every 4 to 6 hours as necessaryfor relief of pain.In controlled analgesic clinical trials, doses of Ibuprofen tabletsgreater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea:

For the treatment of dysmenorrhea, beginningwith the earliest onset of such pain, IBU tablets should be given in adose of 400 mg every 4 hours as necessary for the relief of pain.

HOW SUPPLIED

IBU tablets are available in the following strengths, colors and sizes:

400 mg (white, oval, debossed 4I)

Overbagged with 10 tablets per bag, NDC 55154-1380-0

600 mg (white, caplet, debossed 6I)

Overbagged with 10 tablets per bag, NDC 55154-0741-0

800 mg (white, caplet, debossed 8I)

Overbagged with 10 tablets per bag, NDC 55154-1342-0

Store at room temperature. Avoid excessive heat 40°C (104°F).

Manufactured by:

Dr. Reddy’s Laboratories Louisiana, LLC

Shreveport, LA 71106 USA

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Distributed by: Cardinal Health

Dublin, OH 43017

L43008771118

L40890251118

L42451221118

Revised: April 2019

MEDICATION GUIDE

Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)

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

NSAIDs can cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

° with increasing doses of NSAIDs

° with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

•Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:

° anytime during use

° without warning symptoms

° that may cause death

The risk of getting an ulcer or bleeding increases with:

° past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

° taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”

° increasing use of NSAIDs

° longer use of NSAIDs

° smoking

° drinking alcohol

° older age

° poor health

° advanced liver disease

° bleeding problems

NSAIDs should only be used:

° exactly as prescribed

° at the lowest dose possible for your treatment

° for the shortest time needed

What are NSAIDs?

NSAIDs 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 NSAIDs?

Do not take NSAIDs:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs

• right before or after heart bypass surgery

Before taking NSAIDs, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems

• have high blood pressure

• have asthma

• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks or pregnancy.

• are breastfeeding or plan to breast feed

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsterodial Anti-Inflammatory Drugs (NSAIDs)?”

• new or worse high blood pressure • low red blood cells (anemia)

• heart failure • life-threatening skin reactions

• liver problems including liver failure • life-threatening allergic reactions

• kidney problems including kidney failure

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

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

• shortness of breath or trouble breathing • slurred speech

• chest pain • swelling of the face or throat

• weakness in one part or side of your body

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

• nausea • vomit blood

• more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar

• diarrhea • unusual weight gain

• itching • skin rash or blisters with fever

• your skin or eyes look yellow • swelling of the arms, legs, hands and feet

• indigestion or stomach pain • flu-like symptoms

If you take too much of your NSAIDs, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

•Aspirin is an NSAID 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 NSAIDs 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.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not us NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for professionals.

IBU™ Ibuprofen Tablets USP 400 mg, 600 mg, and 800 mg Rx — ANDA# 075682

Manufacturing facility: Dr. Reddy’s Laboratories Louisiana, LLC — Shreveport, LA 71106 USA

Distributed by: Dr. Reddy’s Laboratories, Inc.

For more info, call/contact: 1-888-375-3784

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Distributed by: Cardinal Health

Dublin, OH 43017

L43008771118

L40890251118

L42451221118

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

Revised: April 2019

Package/Label Display Panel

Ibuprofen Tablets, USP

400 mg

10 Tablets

bag label
(click image for full-size original)

Package/Label Display Panel

Ibuprofen Tablets, USP

600 mg

10 Tablets

bag label
(click image for full-size original)

Package/Label Display Panel

Ibuprofen Tablets, USP

800 mg

10 Tablets

bag label
(click image for full-size original)
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-1380(NDC:0904-5853)
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
MICROCRYSTALLINE CELLULOSE
COPOVIDONE K25-31
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYSORBATE 80
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 4I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-1380-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-1380-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 06/10/2009
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-0741(NDC:0904-5854)
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
MICROCRYSTALLINE CELLULOSE
COPOVIDONE K25-31
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYSORBATE 80
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 6I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-0741-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-0741-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 06/10/2009
IBUPROFEN
ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-1342(NDC:0904-5855)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
COPOVIDONE K25-31
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYSORBATE 80
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 8I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-1342-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BAG (55154-1342-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075682 06/10/2009
Labeler — Cardinal Health (603638201)

Revised: 05/2021 Cardinal Health

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