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

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Ibuprofen

CHAIN DRUG MARKETING ASSOCIATION INC

Quality Choice 44-291


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 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
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
  • 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
  • take with food or milk if upset stomach occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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

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.

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 40ºC (104ºF)
  • see end flap for expiration date and lot number

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

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

Principal display panel

QC®
Quality
Choice

NDC 63868-773-10

Compare to the
Active Ingredient in
ADVIL® TABLETS

Ibuprofen
Ibuprofen USP, 200 mg

Pain Reliever,
Fever Reducer (NSAID)

100 Tablets     Coated Tablets

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

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

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Ibuprofen
Quality-Choice-44-291

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-773
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
cellulose, microcrystalline
POLYDEXTROSE
ferric oxide red
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BROWN 10 mm 44;291 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, PLASTIC
2 24 in 1 BOTTLE, PLASTIC
3 50 in 1 BOTTLE, PLASTIC
4 NDC:63868-773-05 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075010 1988-05-24


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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