FDA Label for Proprinal

Otc - Active Ingredient

Active Ingredient (in each tablet)

Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer

Indications & Usage

Temporarily  relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor arthritis pain
• the common cold
• toothache
• 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
• rash
• shock
• facial swelling
• asthma (wheezing)
• skin reddening
• blisters

Stomach bleeding warning: This product contains an 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 more or for a longer time than directed
• take a blood thinning (anticoagulant) or steroid drug
• have 3 or more alcohol drinks every day while using this product
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Otc - Do Not Use

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Otc - Ask Doctor

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist if you are

• unders a doctor's care for any serious condition
• taking any other drug containing an NSAID
• taking a blood thinning (anticoagulant) or steroid drug
• taking aspirin for heart attack or stroke (ibuprofen may decrease the benefit of aspirin)
  

Otc - When Using

When using this product

• take with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke
  

Otc - Stop Use

Stop use and ask a doctor if

• an allergic reaction occurs, seek medical help right away
• fever gets worse or lasts more than 3 days
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area.
• new symptoms occur
• you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions: do not take more than directed; the smallest effective dose should be used. Adults and children 12 years of age and over:

• 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 take more than 6 tablets in 24 hours unless directed by a doctor

children under 12 years of age: ask a doctor

Otc - Purpose

Ibuprofen...to reduce pain and fever

Inactive Ingredient

Inactive ingredients:

Carnauba Wax, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Clycolate, Stearic Acid, Titanium Dioxide

Package Label.Principal Display Panel