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

HOW SUPPLIED

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

400 mg (white, round shaped, film-coated tablets engraved “IBU” over “400″ on one side).

Bottles of 100 NDC 64380-809-06

Bottles of 500 NDC 64380-809-07

600 mg (white, oval shaped, biconvex film-coated tablets engraved “IBU” over “600″ on one side)

Bottles of 100 NDC 64380-808-06

Bottles of 500 NDC 64380-808-07

800 mg (white, capsule shaped, film-coated tablets engraved “IBU” over “800″ on one side)

Bottles of 100 NDC 64380-807-06

Bottles of 500 NDC 64380-807-07

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Rx only

Manufactured by:

Strides Pharma Science Limited

Puducherry-605 014, India.

Distributed by:

Strides Pharma lnc .

East Brunswick, NJ 08816

Revised: 07/2019

SPL MEDGUIDE

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:
o with increasing doses of NSAIDs o 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:
o anytime during use o without warning symptoms o that may cause death
The risk of getting an ulcer or bleeding increases with :
o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRls”, or “SNRls” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems
NSAIDs should only be used:
o exactly as prescribed o at the lowest dose possible for your treatment o 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 NSAlDS , 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 29weeks 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 and 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. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FOA-1088 or www.fda.gov/medwatch.
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.
Manufactured by: Strides Pharma Science Limited Puducherry — 605 014, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 07/2019 This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

400 mg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600 mg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

800 mg label
(click image for full-size original)
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-809
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code IBU;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-809-06 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-809-07 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-808
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code IBU;600
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-808-06 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-808-07 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
IBUPROFEN ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-807
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
HYPROMELLOSES
SODIUM CITRATE
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code IBU;800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-807-07 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64380-807-06 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 08/24/2018
Labeler — Strides Pharma Science Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 871402375 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)
Establishment
Name Address ID/FEI Operations
Strides Pharma Science Limited 918513263 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 ANALYSIS (64380-807), ANALYSIS (64380-808), ANALYSIS (64380-809), MANUFACTURE (64380-807), MANUFACTURE (64380-808), MANUFACTURE (64380-809), PACK (64380-807), PACK (64380-808), PACK (64380-809)

Revised: 01/2020 Strides Pharma Science Limited

Page 3 of 3 1 2 3

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.