WNC - 1110B - 2019-1101
Drug Labeling and Warnings
Drug Details [pdf]
IBUPROFEN- ibuprofen tablet, coated
WinCo Foods, LLC
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WNC - 1110B - 2019-1101
Active ingredient (in each caplet)
Ibuprofen, USP 200 mg (NSAID 1)
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- the common cold
- minor pain of arthritis
- toothache
- menstrual cramps
- muscular aches
- temporarily reduces fever
Warnings
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- shock
- facial swelling
- skin reddening
- asthma (wheezing)
- 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
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
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- 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
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 |
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| children under 12 years |
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Other information
- store between 20°-25°C (68°-77°F)
- avoid excessive heat above 40°C (104°F)
- read all warnings and directions before use
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, pregelatinized starch, sodium carboxymellose, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
| IBUPROFEN
ibuprofen tablet, coated |
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| Labeler - WinCo Foods, LLC (056098817) |
Revised: 11/2019
Document Id: 9650b6e7-b694-c291-e053-2995a90a6fa1
Set id: 29996af3-2983-41da-a77e-ddb706319683
Version: 2
Effective Time: 20191101
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