Ibuprofen by Polygen Pharmaceuticals LLC
Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Polygen Pharmaceuticals LLC
NDC Code: 52605-114
Ibuprofen 200 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
temporarily relieves minor aches and pain due to:
- backache
- headache
- menstrual cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever
Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:
- 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
- the more or for a longer time than directed
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems such as heartburn
- the stomach bleeding warning applies to you
- you have high blood pressure, heart disease , kidney disease, liver cirrhosis
- you are taking a diuretic
- you have asthma
- 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
- 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
- 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
- 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 occur
Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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
|
- do not use if seal under cap is broken or missing
- see end panel for lot number and expiration date
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
- store between 20-25 °C (68-77 ° F).
1-888-291-7337
CARTON LABEL PDP
NDC: 52605-114-01
Compare to the active ingredient in Advil®
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED TABLETS
SEE NEW WARNINGS INFORMATION
BOTTLE LABEL PDP
NDC: 52605-114-01
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER(NSAID)
100 COATED TABLETS
SEE NEW WARNINGS INFORMATION
CARTON LABEL PDP
NDC: 52605-117-01
Compare to the active ingredient in Advil®
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
100 COATED CAPLETS
SEE NEW WARNINGS INFORMATION
BOTTLE LABEL PDP
NDC: 52605-117-01
IBUPROFEN TABLETS, USP 200 mg
PAIN RELIEVER/ FEVER REDUCER(NSAID)
100 COATED CAPLETS
SEE NEW WARNINGS INFORMATION
| IBUPROFEN
ibuprofen tablet, coated |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| IBUPROFEN
ibuprofen tablet, coated |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
| Labeler - Polygen Pharmaceuticals LLC (962415720) |
| Registrant - Polygen Pharmaceuticals LLC (962415720) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Polygen Pharmaceuticals LLC | 962415720 | RELABEL(52605-117), REPACK(52605-117), MANUFACTURE(52605-117), PACK(52605-117) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
