NDC 0113-2461 Good Sense Childrens Ibuprofen
Ibuprofen Tablet, Chewable Oral
Product Information
What is NDC 0113-2461?
The NDC code 0113-2461 is assigned by the FDA to the product Good Sense Childrens Ibuprofen which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Childrens Ibuprofen is ibuprofen. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-2461-62 1 bottle in 1 carton / 24 tablet, chewable 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 Good Sense Childrens 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) | ORANGE (C48331) |
Shape | ROUND (C48348) |
Size(s) | 13 MM |
Imprint(s) | L461 |
Score | 2 |
Flavor(s) | ORANGE (C73406) |
Product Packages
NDC Code 0113-2461-62
Package Description: 1 BOTTLE in 1 CARTON / 24 TABLET, CHEWABLE in 1 BOTTLE
Price per Unit: $0.13802 per EA
Product Details
What are Good Sense Childrens Ibuprofen Active Ingredients?
- IBUPROFEN 100 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.
Good Sense Childrens Ibuprofen Active Ingredients UNII Codes
- IBUPROFEN (UNII: WK2XYI10QM)
- IBUPROFEN (UNII: WK2XYI10QM) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 310963 - ibuprofen 100 MG Chewable Tablet
Good Sense Childrens Ibuprofen Inactive Ingredients UNII Codes
- ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
- AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
- ASPARTAME (UNII: Z0H242BBR1)
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MANNITOL (UNII: 3OWL53L36A)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- SOYBEAN OIL (UNII: 241ATL177A)
- SUCCINIC ACID (UNII: AB6MNQ6J6L)
Pharmacologic Class(es)
* Please review the disclaimer below.
Good Sense Childrens 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 CHEWABLE TABLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Active Ingredient (In Each Chewable Tablet)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
temporarily:
• reduces fever• relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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• has had stomach ulcers or bleeding problems• takes a blood thinning (anticoagulant) or steroid drug• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)• takes 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 your child:
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.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Do Not Use
• if the child has 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 If
• stomach bleeding warning applies to your child• child has a history of stomach problems, such as heartburn• child has problems or serious side effects from taking pain relievers or fever reducers• child has not been drinking fluids• child has lost a lot of fluid due to vomiting or diarrhea• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke• child has asthma• child is taking a diuretic
Ask A Doctor Or Pharmacist Before Use If The Child Is
• under a doctor’s care for any serious condition• taking any other drug
When Using This Product
• mouth or throat burning may occur; give with food or water• take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
• child experiences any of the following signs of stomach bleeding:• feels faint• vomits blood• has bloody or black stools• has stomach pain that does not get better• child has symptoms of heart problems or stroke:• chest pain• trouble breathing• weakness in one part or side of body• slurred speech• leg swelling• the child does not get any relief within first day (24 hours) of treatment• fever or pain gets worse or lasts more than 3 days• redness or swelling is present in the painful area• any new symptoms appear
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
• chew or crush tablets completely before swallowing• this product does not contain directions or complete warnings for adult use• do not give more than directed• find right dose on chart below. If possible, use weight to dose; otherwise use age.• if needed, repeat dose every 6-8 hours• do not use more than 4 times a day
Dosing Chart | ||
Weight (lb) | Age (yr) | Tablets |
under 24 | under 2 | ask a doctor |
24-35 | 2-3 | 1 |
36-47 | 4-5 | 1 ½ |
48-59 | 6-8 | 2 |
60-71 | 9-10 | 2 ½ |
72-95 | 11 | 3 |
Other Information
• phenylketonurics: contains phenylalanine 6 mg per tablet• store between 20-25°C (68-77°F)• do not use if printed seal under cap is broken or missing
Inactive Ingredients
acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
Questions Or Comments?
1-800-719-9260
Principal Display Panel
For Ages 2 to 11 Years
Chewables
Children’s
Ibuprofen Chewable Tablets, 100mg
Pain Reliever / Fever Reducer (NSAID)
Orange Flavor
Lasts Up To 8 Hours
24 Chewable Tablets
Compare to active ingredient of Children’s Motrin®
100% SATISFACTION GUARANTEED
Chew or Crush Tablets Completely Before Swallowing
* Please review the disclaimer below.