CARE ONE IBUPROFEN - ibuprofen tablet 
American Sales Company

----------

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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 NSAID, which may cause severe stomach bleeding. The chances are higher if you

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 to prevent 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 {CRC Package Only}

adults and children 12 years and older
  • 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 doctor
children under 12 years
  • ask a doctor

Directions {Non-CRC Bottle Only}

Adults and children 12 years and older:

Children under 12 years: ask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxides, 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® {CRC Package Only}

Effective Pain Medicine {CRC Package Only}

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Coated Tablets

See New Warnings Information

Easy to Open Cap {Non-CRC Bottle Only}

This Package for Households Without Young Children {Non-CRC Bottle Only}

Ibuprofen Tablets, 220 mg Carton Image 1

Ibuprofen Tablets, 220 mg Carton Image 1

Ibuprofen Tablets, 220 mg Carton Image 2

Ibuprofen Tablets, 220 mg Carton Image 2


CARE ONE IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-604
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TITANIUM DIOXIDE 
POLYSORBATE 80 
POLYETHYLENE GLYCOL 
Product Characteristics
ColorBROWNScore no score
ShapeROUNDSize10mm
FlavorImprint Code I2
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:41520-604-621 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
124 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-62)
2NDC:41520-604-711 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
250 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-71)
3NDC:41520-604-781 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
3100 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-78)
4NDC:41520-604-851 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
4250 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-85)
5NDC:41520-604-90500 TABLET ( TABLET) in 1 BOTTLENone
6NDC:41520-604-761 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
6120 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-76)
7NDC:41520-604-822 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
7100 TABLET ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (41520-604-82)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209604/13/2004

Labeler - American Sales Company (809183973)

Revised: 05/2009 American Sales Company