FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK 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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Contract Pharmacal Corp.. 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 ache
- 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
- 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)
- have 3 or more alcoholic drinks every day while using this product
- take more or for 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:
Do Not Use
- if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask Doctor Before Use If
- you have problems or serious side effects from taking pain relievers or fever reducers
- the 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, or kidney disease
- you have asthma
- 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
- 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 and of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- 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 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 (1-800-222-1222) right away.
Directions
- do not take more than directed
- the smallest effective dose should be used
Adults and children 12 years of age 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 of age: ■ Ask a doctor
Inactive Ingredients
(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.
(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.
(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.
Questions Or Comments?
Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST
Package Label.Principal Display Panel
New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3909-2
**Compares to the active ingredient in Motrin
®IB
GLUTEN FREE
Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
DYE-FREE
NOT ACTUAL SIZE
New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3846-2
**Compares to the active ingredient in Motrin
®IB
GLUTEN FREE
Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE
New Information: Read Entire Label
CONTRACT PHARMACAL CORPNDC 10267-3852-2
**Compares to the active ingredient in Motrin
®IB
GLUTEN FREE
Ibuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE
* Please review the disclaimer below.