Dosage Form: tablet
Ibuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer DRUG FACTS
ACTIVE INGREDIENT
(in each Tablet)
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever/fever reducer
USES
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- minor pain or 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.
Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.
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 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 DOCTOR
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 before use if you are
- taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
- 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 any other drug
- consuming 3 or more alcohol drinks per day
WHEN USING THIS PRODUCT
- take with food or milk if stomach upset occurs
- long term continuous use ay increase the risk of heart attack or stroke
STOP USE AND ASK A 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 Poison Control Center 1-800-362-0101 (Arizona only) immediately.
DIRECTIONS
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
| Adults and children 12 years and older |
|
| Children under 12 years |
|
OTHER INFORMATION
Other information
- store at 15 – 30°C (59-86°F).
Inactive ingredients
Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.
QUESTIONS OR COMMENTS
Call 1-800-262-5244
Monday though Friday 9AM – 2PM MST
Distributed by:
RejuviLife, Phoenix, AZ
RejuviLife is a trademark of Apotheca Inc.
PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST
NDC 12634-860-01
IBUPROFEN
MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION
Pain Reliever
Fever Reducer
RejuviLife®
100 CAPLETS
200 MG
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA071333 | 09/16/2009 | |
| Labeler - Apotheca Inc. (051457844) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Apotheca Inc. | 051457844 | relabel, repack | |
More Ibuprofen Drug Facts resources
- Ibuprofen Drug Facts Side Effects (in more detail)
- Ibuprofen Drug Facts Dosage
- Ibuprofen Drug Facts Use in Pregnancy & Breastfeeding
- Drug Images
- Ibuprofen Drug Facts Drug Interactions
- Ibuprofen Drug Facts Support Group
- 51 Reviews for Ibuprofen Drug Facts - Add your own review/rating
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