FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- 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?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Pld Acquisitions Llc Dba Av�ma Pharma Solutions. 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 Tablet)
Ibuprofen USP, 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 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
- rash
- blisters
- skin reddening
- 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)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
If an allergic reaction occurs, stop use an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID which may cause sever stomach bleeding. The chance is higher if you:
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
- 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, or kidney disease
- you have asthma
- 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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use And Ask A Doctor If
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or last more than 10 days
- fever gets worse or last more than 3 days
- redness or swelling is present 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 right away (1-800-222-1222).
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and older:
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
- store between 20°-25°C (68°-77°F)
Inactive Ingredients
carnauba wax, croscarmellose sodium, FD&C yellow# 6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/ Fever Reducer (NSAID)
Coated Tablets
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Manufactured by: Avema Pharma Solution
10400 NW 29th terrace
Miami, FL 33172
Product Label
Ibuprofen 200 mg tabletsIbuprofen 200 mg tabletsIbuprofen 200 mg orange tabletIbuprofen 200 mg orange tablet
* Please review the disclaimer below.