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

Menu
Search

IBUPROFEN

SPIRIT PHARMACEUTICALS,LLC

IBUPROFEN 200 MG SOFTGEL CAPSULES


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

Purpose

Pain reliever /fever reducer

IBUPROFEN Uses

  • Temporarily relieves minor aches and pains due to :
    • *headache
    • *toothache
    • *backache
    • *menstrual cramps
    • *the common cold
    • *muscular aches
    • *minor pain of arthritis
  • 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 a nonsteroidal anti-inflammatory drug (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

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or 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 attach 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
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful are
  • 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
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • adults ad children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • *if pain or fever does not respond to 1 capsule, 2 capsules my be used
    • *do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

IBUPROFEN Other information

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store between 20° - 25°C (68° - 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

Ammonium hydroxide, FD&C green no. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitan monooleate, Sorbitol sorbitan

Distributed By: Greenbrier International, Inc. Chesapeake, VA 23320

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Carton

SEE NEW WARNINGS INFORMATION

ASSURED

Compare to the active ingredient
in Advil® Liqui-Gels®*

IBUPROFENsoftgels

LIQUID FILLED IBUPROFEN CAPSULES, 200 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

10 SOFTGELS

IBUPROFEN

IBUPROFEN

IBUPROFEN CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-0009
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 220 mg

Inactive Ingredients

Ingredient Name Strength
AMMONIA
POLYETHYLENE GLYCOLS
GELATIN
FD&C GREEN NO. 3
FERROSOFERRIC OXIDE
water
propylene glycol
MEDIUM-CHAIN TRIGLYCERIDES
POTASSIUM HYDROXIDE
SHELLAC
SORBITAN MONOOLEATE

Product Characteristics

Color Size Imprint Code Shape
GREEN 18 mm 133 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68210-0009-0 10 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079205 2012-05-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.