NDC 41520-604 Care One Ibuprofen
Ibuprofen Tablet, Film Coated Oral
Product Information
What is NDC 41520-604?
The NDC code 41520-604 is assigned by the FDA to the product Care One Ibuprofen which is a human over the counter drug product labeled by American Sales Company. The generic name of Care One Ibuprofen is ibuprofen. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 41520-604-62 1 bottle in 1 carton / 24 tablet, film coated in 1 bottle, 41520-604-71 1 bottle in 1 carton / 50 tablet, film coated in 1 bottle, 41520-604-76 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle, 41520-604-78 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle, 41520-604-85 250 tablet, film coated in 1 bottle , 41520-604-90 500 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Care One Ibuprofen?
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as 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.
Product Characteristics
Color(s) | BROWN (C48332) |
Shape | ROUND (C48348) |
Size(s) | 10 MM |
Imprint(s) | I2 |
Score | 1 |
Product Packages
NDC Code 41520-604-62
Package Description: 1 BOTTLE in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE
NDC Code 41520-604-71
Package Description: 1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE
NDC Code 41520-604-76
Package Description: 1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE
NDC Code 41520-604-78
Package Description: 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
NDC Code 41520-604-85
Package Description: 250 TABLET, FILM COATED in 1 BOTTLE
NDC Code 41520-604-90
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE
Product Details
What are Care One Ibuprofen Active Ingredients?
- IBUPROFEN 200 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.
Care One Ibuprofen Active Ingredients UNII Codes
- 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
Care One Ibuprofen Inactive Ingredients UNII Codes
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- STARCH, CORN (UNII: O8232NY3SJ)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
Pharmacologic Class(es)
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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]
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Care One Ibuprofen Product Label
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.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSES
- 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
Active Ingredient (In Each Tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
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• 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 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 chances are 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• 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 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 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• 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• ask a doctor
adults and children 12 years and older | |
children under 12 years |
Other Information
• read all warnings and directions before use• store at 20-25°C (68-77°F)• avoid high humidity and excessive heat above 40°C (104°F)• see end panel for lot number and expiration date
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
Questions Or Comments?
1-800-719-9260
Principal Display Panel
Compare to the active ingredient in Advil® Ibuprofen Tablets
IBUPROFEN Tablets, 200mg
Pain Reliever/Fever Reducer (NSAID)
Actual Size
Easy to Swallow
Gluten Free
50 TABLETS
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