Ibuprofen

Read all product information before using. Keep this box for important information.

Drug Facts

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

• 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

Label information

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.

Label information

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.

Brown Film-Coated Caplets contain FD+C Yellow No. 5 (tartrazine) as a color additive

Label information

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

Label information

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

Label information

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

Label information

When using this product

• take with food or milk if stomach upset occurs

Label information

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

Label information

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.

Label information

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)

• 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

Orange, Round-shaped Tablet, debossed with BI 02

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10, FD&C Blue #2, FD&C Yellow #6, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide.

White, Round-shaped Tablet, debossed with BI 04

Colloidal Silicon Dioxide, Croscarmellose Sodium, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide.

Brown, Round-shaped Tablet, debossed with BI 06

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide.

Call 1-844-374-0016 Monday through Friday 9AM - 5PM EST.

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

Orange, Round-shaped Tablet, debossed with BI 02

Quantity : 50864 Tablets

NDC No.: 11788-002-00

[Image in the official label — see DailyMed source]

White, Round-shaped Tablet, debossed with BI 04

Quantity : 50864 Tablets

NDC No.: 11788-004-00

[Image in the official label — see DailyMed source]

Brown, Round-shaped Tablet, debossed with BI 06

Quantity : 50864 Tablets

NDC No.: 11788-006-00

[Image in the official label — see DailyMed source]