Berkley and Jensen Naproxen Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Berkley and Jensen Naproxen Sodium

BJWC

BJWC Naproxen Sodium Tablets, 220 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

  •  Naproxen sodium 220 mg
  •  (naproxen 200 mg) (NSAID)*
  •  *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Berkley and Jensen Naproxen Sodium 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

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

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 applies to you
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • •you are taking a diuretic
  • •you have problems or serious side effects from taking pain relievers or fever reducers
  • •you have asthma

Ask a doctor or pharmacist before use if you are

  • •under a doctor’s care for any serious condition
  • •taking any other drug

When using this product

  • •take with food or milk if stomach upset occurs
  • •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have stomach pain that does not get better
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •you have difficulty swallowing
  • •it feels like the pill is stuck in your throat
  • •redness or swelling is present in the painful area
  • •any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use naproxen sodium 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
  • •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

Berkley and Jensen Naproxen Sodium Other information

  • •each caplet contains: sodium 21 mg
  • •store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

PAIN RELIEVER/FEVER REDUCER

NAPROXEN SODIUM TABLETS, 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

Compare to the active ingredient of Aleve® Caplets

ACTUAL SIZE

220 mg EACH

**CAPSULE-SHAPED TABLETS

GLUTEN FREE

Berkley and Jensen Naproxen Sodium

Naproxen Sodium TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-368
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE (Light Blue) 12 mm L368 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68391-368-87 300 in 1 BOTTLE
2 NDC:68391-368-79 400 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074661 2007-09-17


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Be sure to consult your doctor before taking any medication!
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