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Ibuprofen by Velocity Pharma

Medically reviewed on May 16, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Velocity Pharma
NDC Code: 76168-012

Ibuprofen Tablets, USP 200mg

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
  • toothache
  • backache
  • menstrual cramps
  • minor pains of arthritis
  • muscular aches
  • the common cold
  • temporarily reduces fever

Warnings

Allergy alert: This product may cause a severe allergic reaction, especially in people allergic to aspirin, symptoms may include

  • hives
  • facial swelling
  • asthma(wheezing)
  • shock
  • skin reddning
  • 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

  • this product if you have ever had an allergic reaction to any pain reliever/fever reducer
  • right before or after heart surgery

ask your 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

ask your 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 the benefit of aspirin
  • taking any other drug

when using this product

  • take with food or milk
  • The risk of heart attack or stroke may increase if you are more than directed or for longer than directed

Stop use and ask a doctor if:

  • you experience and 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 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.

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 persists.
  • 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
  • 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)
  • do not use if imprinted safety seal under the cap is broken or missing

Inactive Ingredients

Colloidal silicon Dioxide, Croscarmellose Sodium, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

Questions or Comments

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-012-08 – 40 COUNT

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 1500 
POLYVINYL ALCOHOL 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code114
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-012-0840 CARTON (TABLET) in 1 BOTTLE
11 TABLET, COATED (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123907/01/2012
Labeler - Velocity Pharma (962198409)

 
Velocity Pharma

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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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