Active Ingredient (In Each Tablet)
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Ibuprofen (NDC 54868-5623). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| 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 |
acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
1-800-719-9260
junior strength Ibuprofen tablets, 100 mg
Pain Reliever/Fever Reducer (NSAID)
Lasts up to 8 hours
NDC 54868-5623-0Compare to Motrin® Junior Strength active ingredient
See New Warnings Information
FOR AGES 2 TO 11
* Please review the disclaimer below.