FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Strides Consumer Llc. 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 yellow 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
- rash
- blisters
- shock
- skin reddening
- asthma (wheezing)
- 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 ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask A Doctor Before Use
- 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, 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 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 3days
- 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 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 |
|
| children under 12 years |
|
Other information
- store between 20 – 25°C (68-77°F)
- do not use if imprinted text 'SEALED for YOUR PROTECTION' on safety seal under cap is broken or missing
- see end panel for lot number and expiry date
- sodium free
- each tablet contains 0.714 mg of Magnesium
Inactive Ingredients
colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin.
Questions Or Comments?
Call 1-844-368-7746 (toll free)
Manufactured by:
Strides Pharma Science Ltd
605014, India.
PON/DRUGS/16 13 4193
Distributed by:
Strides Consumer LLC,
East Brunswick, NJ 08816
Licensed user of trademark @2019 Strides Consumer LLC
www.nuprin.com
Package Label.Principal Display Panel
Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
See New Warnings
NDC 72927-805-02
24 Coated Tablets
Nuprin®
IBUPROFEN TABLETS, USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drug
Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
See New Warnings
NDC 72927-805-01
100 Coated Tablets
Nuprin®
IBUPROFEN TABLETS, USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drug
* Please review the disclaimer below.