Drugplain

Berkley and Jensen Naproxen Sodium 220 mg/1

Naproxen Sodium · TABLET, FILM COATED · BJWC

No Recall History
Plain English

Berkley and Jensen Naproxen Sodium is a tablet, film coated containing naproxen sodium at 220 mg/1, taken oral. Manufactured by BJWC.

Key Facts

Brand Name
Berkley and Jensen Naproxen Sodium
Generic Name
Naproxen Sodium
NDC Code (Product)
68391-368
Manufacturer
BJWC
Strength
220 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA074661
Marketing Start
09/17/2007

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Dosage & Administration

Directions • do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose Adults and children 12 years and older: • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period Children under 12 years: • ask a doctor

Warnings

Warnings Allergy alert: Naproxen sodium 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 chance is 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 any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • the stomach bleeding warning appli

Frequently Asked Questions

What is Berkley and Jensen Naproxen Sodium used for?

Berkley and Jensen Naproxen Sodium contains Naproxen Sodium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Berkley and Jensen Naproxen Sodium a controlled substance?

Berkley and Jensen Naproxen Sodium is not classified as a controlled substance by the DEA.

What is the generic name for Berkley and Jensen Naproxen Sodium?

The generic name for Berkley and Jensen Naproxen Sodium is Naproxen Sodium. There are 12 other brand versions of Naproxen Sodium.

What is the NDC code for Berkley and Jensen Naproxen Sodium 220 mg/1?

The NDC (National Drug Code) for Berkley and Jensen Naproxen Sodium 220 mg/1 is 68391-368, listed by BJWC.