IBUPROFEN

SPIRIT PHARMACEUTICALS,LLC

IBUPROFEN 200 MG SOFTGEL CAPSULES

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each Capsule)
• Purpose
• IBUPROFEN Uses
• Warnings
  • Allergy alert
  • Stomach bleeding warning
  • 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
• Directions
• IBUPROFEN Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

Purpose

Pain reliever /fever reducer

IBUPROFEN Uses

• Temporarily relieves minor aches and pains due to :
  • *headache
  • *toothache
  • *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 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

• the stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have 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 attach 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
• stomach pain or upset gets worse or lasts
• redness or swelling is present in the painful are
• 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
• do not take longer than 10 days, unless directed by a doctor (see Warnings)
• adults ad 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 my 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 between 20° - 25°C (68° - 77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients

Ammonium hydroxide, FD&C green no. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitan monooleate, Sorbitol sorbitan

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Carton

SEE NEW WARNINGS INFORMATION

ASSURED™

Compare to the active ingredient
in Advil^® Liqui-Gels^®*

IBUPROFENsoftgels

LIQUID FILLED IBUPROFEN CAPSULES, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

10 SOFTGELS