FILM COATED IBUPROFEN
-
ibuprofen tablet
Family Dollar
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Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- toothache
- 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 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 steriod drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, napraxen, 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 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
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
- 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
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 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
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, fumes silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide
Principal Display Panel
NDC 55319-291-12
FAMILY DOLLAR®
100% SATISFACTION GUARANTEED OR YOUR MONEY BACK
COMPARE TO THE ACTIVE INGREDIDENT IN ADVIL® TABLETS*
Film Coated
Ibuprofen Tablets
Pain Reliever • Fever Reducer (NSAID)
SEE NEW WARNINGS INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPIS BROKEN OR MISSING
50844 REV0910B29112
DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.
10401 MONROE ROAD
MATTHEWS, NC 28105 USA
Product Packaging
| FILM COATED IBUPROFEN
ibuprofen tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075010 | 05/24/1988 | |
| Labeler - Family Dollar (024472631) |
Revised: 09/2011 Family Dollar