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CounterAct IB Content of Label


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each white tablet)Ibuprofen USP, 200 mg (NSAID)**nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

PurposePain reliever/fever reducer


INDICATIONS & USAGE SECTION

Use

  • temporarily relieves minor aches and pains due to:
  • headachethe common coldtoothachemuscular achesbackacheminor pain of arthritismenstrual cramps
  • temporarily relieves fever

WARNINGS SECTION

WarningsAllergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does 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 the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • the smallest effective dose should be used

STORAGE AND HANDLING SECTION

Other information

  • store at controlled room temperature
  • avoid excessive heat 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients  cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin


OTC - QUESTIONS SECTION

Questions or comments?call 1-800-282-3000


BOXED WARNING SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL