Ibuprofen: Package Insert and Label Information (Page 3 of 3)

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see HOW SUPPLIED section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(400 mg / 100 UD) NDC 60687-446-01 packaged from NDC 65162-464
(600 mg / 100 UD) NDC 60687-457-01 packaged from NDC 65162-465
(800 mg / 100 UD) NDC 60687-468-01 packaged from NDC 65162-466

Distributed by:
American Health Packaging
Columbus, OH 43217

8444601/0319

Medication Guide

8444601/0319
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal 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 doses 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 take NSAIDs?
Do not take NSAIDs:

  • if you have 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 of 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 of 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 Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting and dizziness.

Get emergency help right away if you get 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 taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or 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, legs, hands, and feet

If you take too much of your NSAID, 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 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 use 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 health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

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

Distributed by:
American Health Packaging Columbus, OH 43217

8444601/0319

Package/Label Display Panel – Carton – 400 mg

400 mg Ibuprofen Tablets Carton
(click image for full-size original)

NDC 60687- 446 -01

Ibuprofen
Tablets, USP

400 mg

100 Tablets (10 x 10) Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Ibuprofen, USP……………………………………………………400 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat 40°C (104°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65162-464, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

744601 0444601/0319

Package/Label Display Panel – Blister – 400 mg

400 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

400 mg

Package/Label Display Panel – Carton – 600 mg

600 mg Ibuprofen Tablets Carton
(click image for full-size original)

NDC 60687- 457 -01

Ibuprofen
Tablets, USP

600 mg

100 Tablets (10 x 10) Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Ibuprofen, USP……………………………………………………600 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat 40°C (104°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65162-465, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

745701 0445701/0319

Package/Label Display Panel – Blister – 600 mg

600 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

600 mg

Package/Label Display Panel – Carton – 800 mg

800 mg Ibuprofen Tablets Carton
(click image for full-size original)

NDC 60687- 468 -01

Ibuprofen
Tablets, USP

800 mg

100 Tablets (10 x 10) Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Film-Coated Tablet Contains:
Ibuprofen, USP……………………………………………………800 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat 40°C (104°F).

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is
torn or broken.

The drug product contained in this package is from
NDC # 65162-466, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

746801 0446801/0319

Package/Label Display Panel – Blister – 800 mg

800 mg Ibuprofen Tablet Blister
(click image for full-size original)

Ibuprofen Tablet, USP

800 mg

IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-446(NDC:65162-464)
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (Biconvex) Size 13mm
Flavor Imprint Code IP;464
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-446-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-446-11)
1 NDC:60687-446-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-446-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-457(NDC:65162-465)
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
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (Biconvex) Size 17mm
Flavor Imprint Code IP;465
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-457-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-457-11)
1 NDC:60687-457-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-457-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-468(NDC:65162-466)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code IP;466
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-468-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-468-11)
1 NDC:60687-468-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-468-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078558 06/01/2019
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-446), repack (60687-457), repack (60687-468)

Revised: 11/2020 American Health Packaging

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