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Naproxen Capsules

Pronunciation

Generic Name: naproxen sodium
Dosage Form: capsule, liquid filled

Drug Facts

Active ingredient(in each capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

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*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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 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
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
  • if taken with food, this product may take longer to work

Adults and children 12 years and older:

  • take 1 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12-hour period
  • do not exceed 3 capsules in a 24-hour period

Children under 12 years

  • ask a doctor

Other information

  • each capsule contains:sodium 20 mg
  • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
  • do not use if carton is open or if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing.
  • do not use if Tamper-Evident seal under bottle cap is broken or missing.
  • read all directions and warnings before use. Keep carton.

Inactive ingredients   FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

                                                                               Manufactured by:
                                                                          Banner Pharmacaps Inc.
                                                                               4125 Premier Drive
                                                                             High Point, NC 27265

Principal Display Panel-Shipping Label

NDC 10888-7121

Naproxen sodium, 220 mg

(Liquid Filled Capsules)

6,000 Softgels

IMPORTANT

This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.

CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY

BANNER PHARMACAPS INC. BULK LABEL

NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10888-7121
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
LACTIC ACID  
MANNITOL  
POLYETHYLENE GLYCOL  
POVIDONE  
PROPYLENE GLYCOL  
WATER  
SORBITAN  
SORBITOL  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10888-7121-1 1 BAG (BAG) in 1 BOX
1 6000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021920 03/01/2007
Labeler - Banner Pharmacaps Inc. (002193829)
Revised: 07/2010
 
Banner Pharmacaps Inc.



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