FDA Label for Ibuprofen Immediate Release

Active Ingredient(S)

(in each white tablet or caplet**)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                                    

Purpose

Pain reliever/fever reducer

Use(S)

• temporarily relieves minor aches and pains due to:

    • headache

    • muscular aches

    • minor pain of arthritis

    • toothache

    • backache

    • the common cold

    • menstrual cramps

• temporarily reduces fever

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling      
• asthma (wheezing)
• shock        
• skin reddening     
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

 Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

• if you have ever had an allergic reaction to ibuprofen or any other pain reliever / fever reducer
• right before or after heart surgery       

Ask A Doctor Before Use If

• you have problems or serious side effects from taking pain relievers or fever reducers
• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

• taking aspirin for heart attack or stroke, because ibuprofen USP may decrease this benefit of aspirin
• under a doctor's care for any serious condition
• taking any other drug

When Using This Product

• take with food or milk if stomach upset occurs

Stop Use And Ask Doctor If

• you experience any of the following signs of stomach bleeding:   
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:   
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    
    

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away.(1-800-222-1222)

Directions

• do not take more than directed

• the smallest effective dose should be used  

OTHER INFORMATION

• store between 20 – 25°C (68-77°F)
• do not use if imprinted text "SEALED for YOUR PROTECTION" on the safety seal under cap is broken or missing
• see end panel for lot number and expiration date
• Very low sodium
• Each tablet contains 0.714 mg of Magnesium

Inactive Ingredient (S)

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?

Call 1-855-742-7868

Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India

PON/DRUGS/16134193

Distributed by:

Strides Pharma Inc

East Brunswick, NJ 08816

July 2017

Principal Display Panel

Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

NDC 59556-811-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

24 Coated round coated - 7e157205 963c 4486 988e b78bff4bfa37 01

Package Label (Capsule Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

NDC 59556-812-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug