FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- 20'S CARTON
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
Purpose
Pain reliever/Fever reducer
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- 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 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.
- 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. - if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do not use
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, asthma, or had a stroke
- 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
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
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 right away.
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° to 25°C (68° to 77°F)
- avoid excessive heat above 40°C (104°F). Protect from light.
Inactive Ingredients
FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
Questions Or Comments?
call toll-free 1-888-309-9030
Other
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
†This product is not manufactured or distributed by the owners of Advil ® LIQUI-GELS ®.
DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED! (888) 309-9030
L0000741
R0823
20'S Carton
DG health
Compare to the active
ingredient of Advil
®
LIQUI-GELS
®†
Ibuprofen
Capsules, 200 mg
Pain Reliever/Fever Reducer
(NSAID)
200 mg
20 Softgels**
(**Liquid Filled Capsules)
Actual Size
* Please review the disclaimer below.