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Ibuprofen by Avema Pharma Solutions

Medically reviewed on June 4, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Avema Pharma Solutions
NDC Code: 63548-0234

Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP, 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 an 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, or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are
  • under a doctor's 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
    • have bloody or black stools  
    • vomit blood
    • 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 20-25ºC (68-77ºF)

Inactive ingredients

carnauba wax, croscarmellose sodium, FD&C yellow #6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

COATED TABLETS

Manufactured by: Avema Pharma Solution

10400 NW 29th Terrace

Miami, FL 33172

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

Product Label

Avema Pharma Solutions Ibuprofen 200 mg Tablet, Orange

Avema Pharma Solutions Ibuprofen 200 mg Tablet, Orange

Avema Pharma Solutions Ibuprofen 200 mg Tablet, Orange

Avema Pharma Solutions Ibuprofen 200 mg Tablet, Orange

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code52
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-0234-21 BOTTLE (1 BOTTLE) in 1 BOX
1100 TABLET, COATED (100 TABLET) in 1 BOTTLE
2NDC:63548-0234-110 TABLET, COATED (10 TABLET) in 1 VIAL
3NDC:63548-0234-31000 TABLET, COATED (1000 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07646008/01/2013
Labeler - Avema Pharma Solutions (804087794)

 
Avema Pharma Solutions

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Further information

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

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