NDC 52605-117 Ibuprofen

Active Ingredient(S)

Ibuprofen 200 mg (NSAID)*  * nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Use(S)

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

Warnings

• Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) blisters facial swelling hives rash shock skin reddeningIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product the 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 reducerright 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 you have a history of stomach problems such as heartburn the stomach bleeding warning applies to youyou have high blood pressure, heart disease , kidney disease, liver cirrhosis  you are taking  a diuretic you have asthma

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 aspirintaking 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 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 betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms occurSide effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding

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 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 doctorchildren under 12 years:ask a doctor

Other Information

• Do not use if seal under cap is broken or missingsee end panel for lot number and expiration date

Inactive Ingredient

Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage

• Store between 20-25 °C (68-77 ° F).

Questions

1-888-291-7337