NDC 52605-117 Ibuprofen
Product Information
Ibuprofen is product labeled by Polygen Pharmaceuticals Llc. The product's dosage form is and is administered via form.
What are the uses for Ibuprofen?
Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Product Characteristics
| Color(s) | BROWN (C48332) |
| Shape | ROUND (C48348) CAPSULE (C48336) |
| Size(s) | 10 MM 15 MM |
| Imprint(s) | 114 117 |
| Score | 1 |
Product Packages
NDC 52605-117-01
Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE
Product Details
What are Ibuprofen Active Ingredients?
- IBUPROFEN (UNII: WK2XYI10QM)
- IBUPROFEN (UNII: WK2XYI10QM) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 310965 - ibuprofen 200 MG Oral Tablet
- RxCUI: 310965 - ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet
Inactive Ingredient(s)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- STARCH, CORN (UNII: O8232NY3SJ)
- POLYVINYL ALCOHOL (UNII: 532B59J990)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- STARCH, CORN (UNII: O8232NY3SJ)
- POLYVINYL ALCOHOL (UNII: 532B59J990)
* Please review the disclaimer below.
Patient Education
Ibuprofen
Ibuprofen is pronounced as (eye byoo' proe fen)
Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]
* Please review the disclaimer below.
Ibuprofen Labeling and Warnings
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- STORAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
Active Ingredient(S)
Ibuprofen 200 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer
Use(S)
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
Warnings
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
- 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 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:
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 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
Ask A Doctor Or Pharmacist Before Use If
- 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 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
- 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
Pregnancy/Breastfeeding
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
- do not use if seal under cap is broken or missing
- see end panel for lot number and expiration date
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Storage
- store between 20-25 °C (68-77 ° F).
Questions
1-888-291-7337
Principal Display Panel
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
* Please review the disclaimer below.