Ibuprofen

FRED'S, INC.

Freds 44-393

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each orange caplet)
• Purpose
• Ibuprofen Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Ibuprofen Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each orange caplet)

 Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

 Pain reliever/fever reducer

Ibuprofen Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • toothecahe
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
• 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:

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinnks 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

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

Ask a doctor or pharmacist before use if

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any of 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
• have bloody or black stools
• vomit blood
• 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 complication during delivery.

Keep out of reach of children

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: 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

Ibuprofen Other information

• store between 20º-25ºC (68º-77ºF)
• avoid excess heat 40ºC (104ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

 Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

See New Warnings Information

FRED'S_®

Ibuprofen
Pain Releiver/Fever Reducer (NSAID)

Ibuprofen Tablets, USP 200 mg

100 (Orange) Caplets**
**Capsule-Shaped Tablets

Tested Against The Active Ingredients In:
MOTRIN^® IB CAPLETS^†

^†This product is not manufactured or distributed McNeil Consumer Healthcare, owner of the registered trademark Motrin^® IB Caplets.

50844        REV0411C39312

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BORKEN OR MISSING