Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

Ibuprofen

CVS Pharmacy

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CVS Pharmacy, Inc. Ibuprofen Tablets, 200mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

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
adults and children 12 years and older

 

  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years

 

  • ask a doctor
  • 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, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Motrin® IB†

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Ibuprofen

Caplets

Ibuprofen Tablets, 200mg

Actual size

Pain reliever/Fever reducer (NSAID)

Coated Caplets

**Capsule shaped tablets

Principal Display Panel
Ibuprofen Tablets, 200mg Carton Image 1 Ibuprofen Tablets, 200mg Carton Image 2

Ibuprofen

Ibuprofen TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-517
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
IRON
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE 14 mm I2 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:59779-517-78 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077349 2006-04-27


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Be sure to consult your doctor before taking any medication!
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