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

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Ibuprofen

NASH-FINCH COMPANY

Our Family 44-291


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroifal anti-inflammatory drug

Purpose

 Pain reliever/fever reducer

Ibuprofen Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • toothache
    • muscular aches
    • backaches
    • minor pain of arthritis
    • menstrual cramps
  • 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)
  • skin reddening
  • shock
  • rash
  • blisers

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:

  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • take other drug 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

Do not use

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

Ask a doctor before use if

  • 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

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
    • have bloody or black stools
    • vomit blood
    • 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.

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 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 12 years: ask a doctor

Ibuprofen Other information

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

Inactive ingredients

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

Questions or comments?

 Call 1-800-426-9391 8:30 am-4:00 pm ET, Monday - Friday

Principal Display Panel

Medicines for Body Aches and Pains

Compare to the Active Ingredient of Advil®†

Our Family®
Quality Care Since 1904

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

100 TABLETS

SAFETY SEALED

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

50844        REV0411E29112

DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996
NFC BRANDS, 7600 FRANCE AVE S, MPLS, MN 55435
www.ourfamilyfoods.com     NF16293

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

Ibuprofen
Our Family 44-291

Ibuprofen

Ibuprofen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:70253-291
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
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 50 in 1 BOTTLE, PLASTIC
4 NDC:70253-291-14 500 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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