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

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Ibuprofen

Safeway

Safeway 44-291




FULL PRESCRIBING INFORMATION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

 Pain reliever/fever reducer

  • temporarily relieves minor aches and pains due to:
    • toothache
    • the common cold
    • menstrual aches
    • headache
    • minor pain of arthritis
    • backache
    • muscular aches
  • temporarily reduces fever

 Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, rash, shock, blisters, asthma (wheezing), skin reddening. 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 is 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]
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer 
  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • take with food or milk if stomach upset occurs
  •  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
  • any new symptoms appear
  • redness or swelling is present in the painful area

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)
  • use by expiration date on package

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

NDC 21130-921-03
Compare to Advil® Tablets
active ingredient†

Ibuprofen
Ibuprofen Tablets USP, 200 mg
Pain Reliever / Fever Reducer
(NSAID)

10 TABLETS

SAFEWAY®

OPEN HERE FOR COMPLETE PRODUCT INFORMATION

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Advil® Tablets.
50844        REV0112A29103

TAMPER EVIDENT: DO NOT USE IF IMPRINTED TEAR STRIP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF THIS SAFETY SEAL AROUND CAP IS BROKEN OR MISSING

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION GURANTEED OR YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com / PRODUCT OF USA

 Ibuprofen

SAFEWAY 44-291-03

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-921
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
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
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
3 250 in 1 BOTTLE, PLASTIC
4 50 in 1 BOTTLE, PLASTIC
5 NDC:21130-921-03 10 in 1 VIAL, PLASTIC
6 NDC:21130-921-14 500 in 1 BOTTLE, PLASTIC

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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