Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a380cace-43dc-4b9c-84d3-0b38241d9d2e
Route
ORAL
Published
Effective Date 2022-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Lactic Acid Polyethylene Glycol, Unspecified Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: NP220 Shape: oval Color: blue Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2020-01-31

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

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

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • 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

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 tablet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets within the first hour
    • do not exceed 2 tablets in any 8- to 12-hour period
    • do not exceed 3 tablets 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
Package Label
WALGREENS All Day Pain Relief
Other Information
  • each tablet contains: sodium 20 mg
  • store at 20º to 25°C (68º to 77°F). excursions permitted between 15ºC and 30ºC (59ºF to 86ºF)[See USP Controlled Room Temperature]. Avoid high humidity and excessive heat above 40°C (104°F). Protect from Light. 
  • read all directions and  warnings before use. Keep carton.
  • swallow whole: do not crush, chew or dissolve
Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, polyethylene glycol, sorbitan, sorbitol, white pharmaceutical ink

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in  Aleve® Liquid Gels††

All Day Pain Relief

NAPROXEN SODIUM 

CAPSULES, 220 mg (NSAID) /

PAIN RELIEVER / FEVER REDUCER

12 HOUR

LIQUID GELS**

(**Liquid-filled capsules)

††This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Aleve® Liquid Gels.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product

take with food or milk if stomach upset occurs.

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, kidney disease, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you are taking a diuretic
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problem or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • 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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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 ache
    • backache
    • menstrual cramp
    • headache
    • toothache
    • the common cold
  • temporarily reduces fever
Purposes

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • 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

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 tablet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets within the first hour
    • do not exceed 2 tablets in any 8- to 12-hour period
    • do not exceed 3 tablets 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
Package Label
WALGREENS All Day Pain Relief
Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • store at 20º to 25°C (68º to 77°F). excursions permitted between 15ºC and 30ºC (59ºF to 86ºF)[See USP Controlled Room Temperature]. Avoid high humidity and excessive heat above 40°C (104°F). Protect from Light. 
  • read all directions and  warnings before use. Keep carton.
  • swallow whole: do not crush, chew or dissolve
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, lactic acid, polyethylene glycol, sorbitan, sorbitol, white pharmaceutical ink

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in  Aleve® Liquid Gels††

All Day Pain Relief

NAPROXEN SODIUM 

CAPSULES, 220 mg (NSAID) /

PAIN RELIEVER / FEVER REDUCER

12 HOUR

LIQUID GELS**

(**Liquid-filled capsules)

††This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Aleve® Liquid Gels.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product (When using this product)

take with food or milk if stomach upset occurs.

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, kidney disease, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you are taking a diuretic
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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problem or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • 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, (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. (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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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

All Sections (JSON)