SPL v4
SPL
SPL Set ID a13bd208-f29f-1cbc-e053-2995a90a08ba
Route
ORAL
Published
Effective Date 2022-12-29
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 Mannitol Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: NP1 Shape: capsule Color: blue Size: 25 mm Score: 1
Marketing Status
NDA Active Since 2019-08-02
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
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • 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.

Section 53414-9

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.

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
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 hours 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-hour 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
40's Carton

Walgreens

Compare to ALEVE ® Back & Muscle Pain active ingredient ††

NDC 0363-0102-15

BACK & MUSCLE PAIN

All Day Pain Relief

NAPROXEN SODIUM CAPSULES, 220 mg (NSAID) / PAIN RELIEVER / FEVER REDUCER

BACK & MUSCLE PAIN

12 HOUR LIQUID GELS

• For temporary relief of minor back & muscle aches & pains

40 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

Other Information
  • each capsule contains: sodium 20 mg
  • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light.
  • read all directions and warnings before use. Keep carton.
Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions Or Comments?

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • 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
  • 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
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
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:
    • backache
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • 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.

Section 53414-9 (53414-9)

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.

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
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 hours 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-hour 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
40's Carton (40's carton)

Walgreens

Compare to ALEVE ® Back & Muscle Pain active ingredient ††

NDC 0363-0102-15

BACK & MUSCLE PAIN

All Day Pain Relief

NAPROXEN SODIUM CAPSULES, 220 mg (NSAID) / PAIN RELIEVER / FEVER REDUCER

BACK & MUSCLE PAIN

12 HOUR LIQUID GELS

• For temporary relief of minor back & muscle aches & pains

40 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

Other Information (Other information)
  • each capsule contains: sodium 20 mg
  • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light.
  • read all directions and warnings before use. Keep carton.
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions Or Comments? (Questions or comments?)

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

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)
  • 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
  • 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
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:27.084823 · Updated: 2026-03-14T23:00:53.570671