FDA Label for Ibuprofen Softgels

Active Ingredient (In Each Capsule)

Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)* 

*nonsteroidal anti-inflammatory drug

Purpose

fever reducer (present as the free acid and potassium salt)

Drug Facts (continued)

Uses

_ temporarily relieves minor aches and pains due to:

_ muscular aches

_ the common cold

_ headache

_ toothache

_ backache

_ menstrual cramps

_ 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:

_ blisters

_ rash

_ hives

_ asthma (wheezing)

_ shock

_ skin reddening

_ facial swelling

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:

_ take a blood thinning (anticoagulant) or

Drug Facts (continued)

steroid drug

_ are age 60 or older

_ have had stomach ulcers or bleeding problems

_ 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 a history of stomach problems, such as heartburn

_ you are taking a diuretic

Drug Facts (continued)

_ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma

_ you have problems or serious side effects from taking pain relievers or fever reducers

Ask A Doctor Or Pharmacist Before Use If You Are

_ taking any other drug

_ under a doctor's care for any serious condition

_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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

Drug Facts (continued)

stomach bleeding:

_ feel faint

_ have stomach pain that does not get better

_ have bloody or black stools

_ vomit blood

_ 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 right away. (1-800-222-1222)

Drug Facts (continued)

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

Other Information

_ each capsule contains: potassium 28 mg

_ read all warnings and directions before use.

_ store at 20°-25°C (68°-77°F)

_ avoid excessive heat above 40°C (104°F)

Drug Facts (continued)

Inactive Ingredients

FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink

Questions Or Comments?

1-800-901-2420

Product of China

Principal Display Panel

b+b
better by giving
IBUPROFEN
SOFTGELS
20 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANELb+bbetter by givingIBUPROFENSOFTGELS20 Softgels(200 mg each) - ibuprofen softgels 01

b+b
better by giving
IBUPROFEN
SOFTGELS
40 Softgels
(200 mg each)