Ibuprofen

Freds Inc

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• Ibuprofen Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • 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
• Product Label

FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Ibuprofen Uses

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

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 a nonsteroidal anti-inflammatory drug (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

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

Ask a doctor or pharmacist before use if you are

• 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 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 (1-800-222-1222) 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 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

Ibuprofen Other information

• each capsule contains: potassium 20 mg
• read all warnings and directions before use. Keep carton
• store at 20° to 25°C (68° to 77°F)
• avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

Questions or Comments?

Call toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Ibuprofen Capsules, 200 mg

Pain reliever/ fever reducer (NSAID)

40 CAPSULES

SOFT GELATIN CAPSULES**

**(liquid filled capsules)

Compare to the active ingredient in Advil® Liqui- Gels® †

†This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Do not use if seal under cap imprinted with "SEALED FOR YOUR PROTECTION" is broken or missing.

Product Label