Ibuprofen IB 200 mg/1
Ibuprofen · TABLET, COATED · WINCO FOODS, LLC
Ibuprofen IB is an over-the-counter nonsteroidal anti-inflammatory drug available as a 200 mg coated tablet taken by mouth, commonly used to reduce fever and relieve mild to moderate pain such as headaches, muscle aches, and menstrual cramps. It works by reducing substances in the body that cause inflammation, pain, and fever.
Key Facts
- Brand Name
- Ibuprofen IB
- Generic Name
- Ibuprofen
- NDC Code (Product)
67091-368- Manufacturer
- WINCO FOODS, LLC
- Strength
- 200 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202312
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 04/01/2020
Recall History
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches • minor pain of arthritis • toothache • backache • the common cold • temporarily reduces fever
Dosage & Administration
Directions • do not take more than directed • the smallest effective dose should be used adults and children 12 years and older • take 1 caplet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 caplet, 2 caplets may be used • do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years • ask a doctor
Warnings
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 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 • 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 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. Do not use • if you have 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 • you have problems or serio…
Frequently Asked Questions
What is Ibuprofen IB used for?
Ibuprofen IB is an over-the-counter nonsteroidal anti-inflammatory drug available as a 200 mg coated tablet taken by mouth, commonly used to reduce fever and relieve mild to moderate pain such as headaches, muscle aches, and menstrual cramps. It works by reducing substances in the body that cause inflammation, pain, and fever.
Is Ibuprofen IB a controlled substance?
Ibuprofen IB is not classified as a controlled substance by the DEA.
What is the generic name for Ibuprofen IB?
The generic name for Ibuprofen IB is Ibuprofen. There are 12 other brand versions of Ibuprofen.
What is the NDC code for Ibuprofen IB 200 mg/1?
The NDC (National Drug Code) for Ibuprofen IB 200 mg/1 is 67091-368, listed by WINCO FOODS, LLC.