CounterAct IB Content of Label
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each tablet)
Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual cramps
- temporarily reduces fever
WARNINGS SECTION
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe bleeding. The chances are higher if you:
- hives
- facial swelling
- asthma (wheezing)shock
- skin reddening
- rash
- blisters
OTC - DO NOT USE SECTION
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 SECTION
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- you are taking a diuretic
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- taking any other drug
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
OTC - WHEN USING SECTION
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 SECTION
Stop use and ask a doctor if
- you experience any of the following signs of bleeding:
- feel faintvomit bloodhave blood ro black stoolshave 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 (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 12 years and older:
- do not take more than directed
- the smallest effective dose should be used
STORAGE AND HANDLING SECTION
Other information
- Store between 20 to 25°C (68 to 77°F)
- Read all warnings and directions before use
- save carton for complete drug facts information and warnings
INACTIVE INGREDIENT SECTION
Carnuba Wax, Corn Starch, Fumed Silica Gel, Hypromellose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Red Iron Oxide, Stearic Acid, Sodium Starch Glycolate, Titanium Dioxide
OTC - QUESTIONS SECTION
Questions of comments? call 1-800-282-3000
BOXED WARNING SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING