Otc - Active Ingredient
Active Ingredient (in each tablet)
Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer
The following Structured Product Label (SPL) was submitted to the FDA by Normed for the product Proprinal (NDC 50332-0109). 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 otc - active ingredient, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each tablet)
Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer
Temporarily relieves minor aches and pains due to:
Temporarily reduces fever
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist if you are
When using this product
Stop use and ask a doctor if
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. Adults and children 12 years of age and over:
children under 12 years of age: ask a doctor
Ibuprofen...to reduce pain and fever
Inactive ingredients:
Carnauba Wax, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Clycolate, Stearic Acid, Titanium Dioxide
* Please review the disclaimer below.