Pain Relief

P and L Development of New York Corporation

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each caplet)
  • Purpose
• Pain Relief 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
  • Pain Relief Other information
• Inactive Ingredients
• Questions or comments?
• Principal Display Panel
• Product Label

FULL PRESCRIBING INFORMATION

Active Ingredient (in each caplet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever/ Fever Reducer

Pain Relief 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

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:

• are age 60 or oder
• have had stomach ulcers or bleeding problems
• take blood thinning (anticoagulant) or steroid drug
• have 3 or more alcoholic drinks everyday while using this prdouct
• take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• take more or for a longer time than directed.

Do not use

• if you ever had an allergic reaction to 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, or kidney disease
• you have asthma
• 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 last more than 10 days
  • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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

:

Other information

• store between 20^o- 25^o C (68^o- 77^o F)
• read all warnings and directions before use. Keep carton

Inactive Ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Questions or comments?

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

Principal Display Panel

Pain Relief

Ibuprofen Tablets USP, 200 mg

Pain Reliever/ Fever Reducer (NSAID)*

†Compare to the active ingredient in ADVIL®

†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 IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING

Product Label