FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 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?
- PRINCIPAL DISPLAY PANEL
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product L.n.k. International, 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 Ingredients
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains associated with
- headache
- menstrual cramps
- toothache
- backache
- minor arthritis pain
- the common cold
- 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
- skin reddening
- asthma (wheezing)
- facial swelling
- rash
- blisters
- 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
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:
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.
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
- you have problems or serious side effects from taking pain relievers or fever reducers
- 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, asthma or had a stroke
- you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- 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
- leg swelling
- slurred speech
- weakness in one part or side of body
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present in the painful area
- any new or unexpected symptoms occur
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 specifically 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 use 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 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. |
Children under 12 years: | Ask a doctor. |
Other Information
- read all product information before usingI store at 68 ̊-77 ̊F (20 ̊-25 ̊C)
- avoid excessive heat 104 ̊F (above 40 ̊C)
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide
*may contain
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET,
Monday-Friday
Principal Display Panel
NDC 50844-269-24
QUALITY PLUS †
†Compare to active ingredient in Advil® Tablets
IBUPROFEN
TABLETS, 200 mg
PAIN RELIEVER/
FEVER REDUCER (NSAID)
60 Packets of 2 Tablets each
200 mg each
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF PACKET IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
†This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Advil®Tablets.
50844 ORG
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
* Please review the disclaimer below.