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Ibuprofen by TOP CARE (Topco Associates LLC)

Medically reviewed on May 29, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-249

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
    • toothache
    • minor pain of arthritis
    • 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

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 20º-25ºC (68º-77ºF)

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone (K-30), sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

TABLETS

Ibuprofen

Tablets USP 200 mg

  • Pain reliever/Fever reducer (NSAID)

COMPARE TO ADVIL® active ingredient†

COATED TABLETS

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Product of India

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Top Care Ibuprofen Tablet

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-249
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
HYPROMELLOSES 
FERRIC OXIDE RED 
LACTOSE MONOHYDRATE 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeG2
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-249-501 BOTTLE, PLASTIC in 1 BOX
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:36800-249-011 BOTTLE, PLASTIC in 1 BOX
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917404/30/2014
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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