Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 you have
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretic
- reached age 60 or older
Ask a doctor or pharmacist before use if you are
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- 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
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask doctor if
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
- 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
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 PoisonControlCenter right away.
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 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 15 mg
- read all warnings and directions before use. Keep carton.
- store at 20-25°C (68-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- do not use if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing
Inactive ingredients
FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
Manufactured by:
Banner Pharmacaps Inc.
4125 Premier Drive
High Point, NC27265
IMPORTANT
This bulk shipment is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.
CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY.
BANNER PHARMACAPS Inc. BULK LABEL
Principal Display Panel Shipping Label
NDC 10888-7133-1
Ibuprofen 200 mg
(Liquid Filled Capsules)
6,000 Softgels
| 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 | 03/15/2009 | |
| Labeler - Banner Pharmacaps Inc (002193829) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Banner Pharmacaps Inc | 002193829 | MANUFACTURE | |
More Ibuprofen Capsules resources
- Ibuprofen Capsules Side Effects (in more detail)
- Ibuprofen Capsules Use in Pregnancy & Breastfeeding
- Drug Images
- Ibuprofen Capsules Drug Interactions
- Ibuprofen Capsules Support Group
- 51 Reviews for Ibuprofen - Add your own review/rating
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