All Day Pain Relief

All Day Pain Relief
SPL v1
SPL
SPL Set ID db2360dc-1608-4eed-a768-797a8d509f68
Route
ORAL
Published
Effective Date 2013-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Polyethylene Glycol 400 Povidones Croscarmellose Sodium Cellulose, Microcrystalline Silicon Dioxide Water Magnesium Stearate Hypromelloses Titanium Dioxide Fd&c Blue No. 2 Aluminum Oxide

Identifiers & Packaging

Pill Appearance
Imprint: 144 Shape: oval Color: blue Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2013-08-20
Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • headache
    • menstrual 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 Poison Control Center right away. (1-800-222-1222)

Section 53414-9

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.

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 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
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, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments?

1-888-333-9792

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 nonsteroidal 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 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
Active Ingredient (in Each Tablet)

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 any other drug
Principal Display Panel 15 Tablet Bottle Carton

VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE ®*

ALL DAY

PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

  • STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • backache
    • headache
    • menstrual cramps
    • minor pain of arthritis
    • muscular aches
    • the common cold
    • toothache
  • temporarily reduces fever
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 Poison Control Center right away. (1-800-222-1222)

Section 53414-9 (53414-9)

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.

Purpose

Pain reliever/fever reducer

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 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
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, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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 nonsteroidal 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 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
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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 any other drug
Principal Display Panel 15 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 Tablet Bottle Carton)

VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE ®*

ALL DAY

PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

  • STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:41.511512 · Updated: 2026-03-14T22:53:34.467425