Naproxen Sodium 220mg

Naproxen Sodium 220mg
SPL v4
SPL
SPL Set ID 91e1fef2-0e9b-4553-92f2-ddf219990695
Route
ORAL
Published
Effective Date 2017-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 144 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-23

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

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

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information
  • each caplet 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 tamper evident seal under bottle cap is broken or missing
Inactive Ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide

Questions Or Comments?

Call1-800-326-8147

Principal Display Panel

Clear Choice Naproxen
Cear Choice (logo)

NAPROXEN 

SODIUM

(NSAID*)

MODERN PAIN MEDICINE

PAIN & FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Aleve®*

SEE NEW WARNINGS INFORMATION

50 Caplets

220 mg Each

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
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
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
  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

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.

Ask A Doctor Or Pharmacist Before Use If You Are

under a doctor’s care for any serious condition 

  • taking aspirin for heart attack or stroke, because naproxen may

    decrease this benefit of aspirin
  • taking any other drug

Structured Label Content

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
Purpose

Pain reliever/fever reducer

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.  
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
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 heart surgery
Active Ingredient (Active ingredient)

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • each caplet 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 tamper evident seal under bottle cap is broken or missing
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide

Questions Or Comments? (Questions or Comments?)

Call1-800-326-8147

Principal Display Panel

Clear Choice Naproxen
Cear Choice (logo)

NAPROXEN 

SODIUM

(NSAID*)

MODERN PAIN MEDICINE

PAIN & FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Aleve®*

SEE NEW WARNINGS INFORMATION

50 Caplets

220 mg Each

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
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 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
Stop Use and Ask A Doctor If (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
  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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.

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 condition 

  • taking aspirin for heart attack or stroke, because naproxen may

    decrease this benefit of aspirin
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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