Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4db86c5b-62bb-4638-9f1e-98dc2680d6cc
Route
ORAL
Published
Effective Date 2024-01-23
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 Lecithin, Soybean Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Light Mineral Oil Butyl Alcohol Shellac Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PC19 Shape: capsule Color: blue Size: 20 mm Score: 1
Marketing Status
ANDA Active Since 2019-06-30

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 aches
    • backache
    • menstrual cramps
    • 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
  • 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

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 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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label
ALLDAYRELIEF- NAPROXEN SODIUM CAPSULES, 220 mg (NSAID)
Other Information
  • each capsule contains: sodium 20 mg 
  • store between 20-25°C (68-77ºF). Avoid high humidity and excessive heat above 40°C (104ºF).
  • protect from light
  • read all directions and warnings before use. Keep carton.
Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol,  povidone , propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink

Principal Display Panel

STRENGTH TO LAST 12 HOURS

alldayrelief

NAPROXEN SODIUM CAPSULES, 220 mg (NSAID)

PAIN RELIEVER / FEVER REDUCER

LIQUID GELS**

(**Liquid-filled capsules)

Compare to the active ingredient in Aleve®Liquid Gels

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 PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

When Using This Product,

take with food or milk if stomach upset occur.

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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
  • 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 at 20 weeks or later in 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 aches
    • backache
    • menstrual cramps
    • 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
  • 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

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 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
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
Product Label
ALLDAYRELIEF- NAPROXEN SODIUM CAPSULES, 220 mg (NSAID)
Other Information (Other information)
  • each capsule contains: sodium 20 mg 
  • store between 20-25°C (68-77ºF). Avoid high humidity and excessive heat above 40°C (104ºF).
  • protect from light
  • read all directions and warnings before use. Keep carton.
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol,  povidone , propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink

Principal Display Panel

STRENGTH TO LAST 12 HOURS

alldayrelief

NAPROXEN SODIUM CAPSULES, 220 mg (NSAID)

PAIN RELIEVER / FEVER REDUCER

LIQUID GELS**

(**Liquid-filled capsules)

Compare to the active ingredient in Aleve®Liquid Gels

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 PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

When Using This Product, (When using this product,)

take with food or milk if stomach upset occur.

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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
  • 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 at 20 weeks or later in 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

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