Naproxen Sodium Tablets, Usp 220 Mg

Naproxen Sodium Tablets, Usp 220 Mg
SPL v7
SPL
SPL Set ID a690dc39-95f2-4853-a291-05d7dc9a1551
Route
ORAL
Published
Effective Date 2020-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Fd&c Blue No. 2 Hypromelloses Starch, Corn Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 220 Shape: oval Color: blue Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2020-07-02

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrul cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)

Section 53414-9

If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

Section 55105-1

Pain reliever/

fever reducer

Section 55106-9

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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 one tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take within the first hour
  • do not exceed 2 tablets in any 8 to 12 hours period
  • do not exceed 3 tablets in 24 hour period
 Children under 12 years:

  •  Ask a doctor

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after surgery
Allergy Alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information
  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Inactive Ingredients

Colloidal silicon dioxide*, croscarmellose sodium*, FD&C Blue#2 lake, hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.

*contains one or more of these ingredients

Principal Display Panel

CABINET

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

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
Stomach Bleeding Warning

This product contains a non steroidal anti-inflammatory drug(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
Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask A Doctor If
  • you experience any of following sign 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 feel like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning

NSAID's except aspirin increases 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.

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor 's care for any serious conditions
  • taking any other drug

Structured Label Content

Uses
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrul cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

Section 55105-1 (55105-1)

Pain reliever/

fever reducer

Section 55106-9 (55106-9)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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 one tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take within the first hour
  • do not exceed 2 tablets in any 8 to 12 hours period
  • do not exceed 3 tablets in 24 hour period
 Children under 12 years:

  •  Ask a doctor

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after surgery
Allergy Alert (Allergy alert)

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide*, croscarmellose sodium*, FD&C Blue#2 lake, hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.

*contains one or more of these ingredients

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CABINET

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

When Using This Product (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
Stomach Bleeding Warning (Stomach bleeding warning)

This product contains a non steroidal anti-inflammatory drug(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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of following sign 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 feel like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning (Heart attack and stroke warning)

NSAID's except aspirin increases 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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor 's care for any serious conditions
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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