Cvs ibuprofen sodium tablet, film coated

Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

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

  • 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

Ask a doctor or pharmacist before use if you are

  • under a doctors care for any serious condition
  • taking aspirin for 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
  • 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
  • adults and children 12 years and over: 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

Other information

  • each tablet contains:sodium 23 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20-25 C (68-77 F)
  • avoid excessive heat above 40 C (104 F)

Inactive ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, glyceryl monostearate, iron oxide yellow, mannitol, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Cvs ibuprofen sodium tablet, film coated- Ibuprofen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 69842-835
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ibuprofen sodium ( UNII: RM1CE97Z4N)( Ibuprofen - UNII: WK2XYI10QM ) 256 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Ferric oxide yellow ( UNII: EX438O2MRT)
Mannitol ( UNII: 3OWL53L36A)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polyvinyl alcohol, unspecified ( UNII: 532B59J990)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color BROWN Size 10 mm
Shape ROUND Score 1
Imprint Code L1

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA206581 USA

Labeler - CVS Pharmacy( 062312574)

Package/label principal display panel

Compare to the active ingredient in Advil ®(Ibuprofen Sodium) Tablets

Film-Coated Tablets

Ibuprofen Sodium Tablets

IBUPROFEN TABLETS 200 mg

(PROVIDED AS IBUPROFEN SODIUM 256 mg)

Pain Reliever/Fever Reducer (NSAID)

Film-Coated Ibuprofen

Sodium Tablets

80 FILM-COATED TABLETS

Actual Size