GOOD SENSE IBUPROFEN description, usages, side effects, indications, overdosage, supplying and lots more!

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GOOD SENSE IBUPROFEN

L Perrigo Company

Perrigo Ibuprofen Softgels Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Solubilized ibuprofen

equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

GOOD SENSE IBUPROFEN Uses

  • temporarily relieves minor aches and pains 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 allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 an NSAID [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
  • 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 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • asthma
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking aspirin to prevent 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
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • 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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • 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
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • do not use if printed foil under cap is broken or missing
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

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

Questions or comments?

1-800-719-9260

Principal Display Panel

**Liquid Filled Capsules

See Additional Warning

Ibuprofen Softgels**

Solubilized Ibuprofen Capsules 200 mg

Pain Reliever/Fever Reducer (NSAID)

Compare to active ingredient of Advil® Liqui-Gels®

GOOD SENSE IBUPROFEN
Ibuprofen Softgels Carton

GOOD SENSE IBUPROFEN

Ibuprofen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0113-0131
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Product Characteristics

Color Size Imprint Code Shape
GREEN (Light Green) 19 mm 133 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BOTTLE
2 NDC:0113-0131-49 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079205 2010-01-28


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Be sure to consult your doctor before taking any medication!
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