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

Ibuprofen

L.N.K. International, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Ibuprofen Tablets USP, 200 mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

  • 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

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 perscription or nonperscription 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, 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 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.

  • 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 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
  • store between 20º-25ºC (68º-77ºF)
  • avoid excessive heat above 40°C (104°F)
  • see end flap for expiration date and lot number

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Product Packaging

Quality Plus

NDC 50844-291-12

†Compare to the active ingredient in Advil® Tablets.

Ibuprofen Tablets
USP, 200 mg

Pain Reliever / Fever Reducer (NSAID)

100 Film Coated Brown Tablets

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Tablets.
50844    ORG011229112

Manufactured by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Packaging
Quality Plus 44-291

Ibuprofen

ibuprofen TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50844-291
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BROWN 10 mm 44291 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, PLASTIC
2 150 in 1 BOTTLE, PLASTIC
3 40 in 1 BOTTLE, PLASTIC
4 50 in 1 BOTTLE, PLASTIC
5 60 in 1 BOTTLE, PLASTIC
6 12 in 1 BOTTLE, PLASTIC
7 24 in 1 BOTTLE, PLASTIC
8 30 in 1 BOTTLE, PLASTIC
9 250 in 1 BOTTLE, PLASTIC
10 NDC:50844-291-03 10 in 1 VIAL, PLASTIC
11 NDC:50844-291-14 500 in 1 BOTTLE, PLASTIC
12 NDC:50844-291-16 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075010 1999-03-02


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Be sure to consult your doctor before taking any medication!
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