FDA Label for Ibuprofen

Active Ingredient(S)

200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Use(S)

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

Warnings

  Allergy alerts: 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 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

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of 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

• 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 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 following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that dose not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in painful area
  • any new symptoms appear
  
  

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 a 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 ControlCenter 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 over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever dose 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 20 mg
• read all warnings and directions before use.
• store at 20-25 ^oC (68-77 ^oF)
• avoid excessive heat above 40 ^oC (104 ^oF)

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, Sorbitol, Sorbitan monooleate

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