FDA Label for Ibuprofen

Active Ingredient (In Each Tablet/Caplet)

Ibuprofen 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

Do Not Use

• if you have ever had an allergic reaction to 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, or kidney disease
• you have asthma
• 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

Call 1-877-770-3183:
weekdays 9:00 AM to 4:30 PM EST

Package Label.Principal Display Panel

Do not use if the foil inner seal is broken or missing
NDC# 62207-365-43
See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Tablets**

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing
NDC# 62207-366-43
See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Coated Caplets**
**Capsule-Shaped Tablets

Important: Read all product information before using.