IBUPROFEN
-
ibuprofen capsule, liquid filled
Dolgencorp Inc
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Active ingredient (in each capsule)
Solubilized ibuprofen equal to 200mg ibuprofen (NSAID)* (present as the free acid and potassium salt)
* nonsteroidal anti- inflammatory drug
Uses
- temporarily relieves minor aches and pain due to:
- headache
- muscular aches
- minor pain of arthritis
- toothache
- backache
- the common cold
- 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)
- 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 non prescription NSAIDS [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for 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
- the 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, kidney disease or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if
- 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 longer than directed
Stop use and ask a doctor if
- 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
- stomach pain or upset gets worse or lasts
- 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
- adults and children 12 years and over:
- take 1 capsule every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 capsule, 2 capsules may be used
- do not exceed 6 capsules in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- each capsule contains: potassium 20 mg
- read all warnings and directions before use. Keep carton.
- store at 20°- 25°C (68°- 77°F)
- avoid excessive heat above 40°C (104°F). Protect from light
- do not use if Tamper- Evident seal under botlle cap imprinted with "Sealed for your protection" is broken or missing
Inactive ingredients
FDC Blue no.1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
| IBUPROFEN
ibuprofen capsule, liquid filled |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA078682 | 05/17/2012 | |
| Labeler - Dolgencorp Inc (068331990) |
Revised: 07/2012 Dolgencorp Inc