FDA Label for Ibuprofen

Other

Drug Facts

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

Active Ingredient (In Each Tablet)

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

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
• 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

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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 lake more than directed
• the smallest effective dose should be used

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

Other Information:

• Store between 20°-25°C (68°-77°F)
• Avoid excessive heat above 40°C (104°F)
• do not use if foil inner seal is broken or missing

Inactive Ingredients

colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch, glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

Call toll free: 1-800-456-7077

Principal Display Panel - 200 Mg Pouch Label

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)*

GLUTEN-FREE
2 Coated Tablets

Principal Display Panel - 200 mg Pouch Label - ibu0b 0001 01

Principal Display Panel – 50 Pouches Carton Label

Safetec^®
of America, Inc.

*Compare to the active ingredient in Advil®

NDC 61010-4411-1

Ibuprofen

Ibuprofen Tablets USP, 200 mg

PUSH TO OPEN

Dispense through opening

Pain Reliever/Fever Reducer (NSAID)*

• Relieves minor aches and pains
• Fever reducer
• Coated tablets

GLUTEN-FREE

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel – 50 Pouches Carton Label - ibu0b 0001 02

Principal Display Panel – 100 Pouches Carton Label

Safetec^®
of America, Inc.

*Compare to the active ingredient in Advil®

NDC 61010-4411-2

Ibuprofen

Ibuprofen Tablets USP, 200 mg - Pain Reliever/Fever Reducer (NSAID)*

GLUTEN-FREE

• Relieves minor aches and pains
• Fever reducer
• Coated tablets

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Principal Display Panel – 100 Pouches Carton Label - ibu0b 0001 03