FDA Label for Ibuprofen

Drug Facts

Active ingredient (in each caplet)

Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

• 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 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 A 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

adults and children 12 years and older	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Other Information

• store between 20° to 25°C (68° to 77°F)
• do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. 
• see top panel for lot number and expiration date

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call 1-855-274-4122 

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Code No.: TS/DRUGS/22/2009
Made in India

Package Label-Principal Display Panel - 200 Mg (100 Tablets Bottle)

NDC 58602-801-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets*                   *Capsule-Shaped Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle) - ibuprofen caplets fig1

Package Label-Principal Display Panel - 200 Mg (100 Tablets Container Carton)

NDC 58602-801-21
Ibuprofen Tablets USP
200 mg
Pain Reliever/Fever Reducer (NSAID)
100 Coated Caplets*                 *Capsule-Shaped Tablets
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton) - ibuprofen caplets fig2