FDA Label for Care One Ibuprofen

View Indications, Usage & Precautions

Care One Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever/fever reducer


Uses



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

Warnings



Allergy alert: 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 chances are 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



  • •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

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

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 stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have 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

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)


Directions



  • •do not take more than directed
  • •the smallest effective dose should be used
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctorask a doctor

    adults and children 12 years and older

    children under 12 years


Other Information



  • •read all warnings and directions before use
  • •store at 20-25°C (68-77°F)
  • •avoid high humidity and excessive heat above 40°C (104°F)
  • •see end panel for lot number and expiration date

Inactive Ingredients



colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to the active ingredient in Advil® Ibuprofen Tablets

IBUPROFEN Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

Actual Size

Easy to Swallow

Gluten Free

50 TABLETS


* Please review the disclaimer below.