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Ibuprofen by PuraCap Pharmaceutical LLC

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-319

Ibuprofen Tablets, USP 200 mg

Drug Facts

Active Ingredient (in each tablet)

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 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

Heart attack and stroke warning: NSAIDs except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 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

  • Store between 20° – 25°C (68 – 77°F). [See USP Controlled Room Temperature]
  • Avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

CVS Ibuprofen Tablets USP, 200 mg

NDC 51013-319-54

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-319
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE K30 
STEARIC ACID 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2208 (100 MPA.S) 
TRIACETIN 
LACTOSE MONOHYDRATE 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG;2
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-319-5415 POUCH in 1 CARTON
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917411/09/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Granules India Limited918609236MANUFACTURE(51013-319)

 
PuraCap Pharmaceutical LLC

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Medically reviewed on Nov 9, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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