SPL v4
SPL
SPL Set ID 462a7e41-b899-4e08-8113-b48ece0ad8d8
Route
ORAL
Published
Effective Date 2022-05-19
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:
    • minor pain of arthritis
    • muscular aches
    • backache
    • 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

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.

Purposes

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
  • 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
Other Information
  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°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
  • 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
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
Principal Display Panel 220 Mg Capsule Bottle Carton

NDC 0363-0177-11

Walgreens

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

20 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

ACTUAL SIZE


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
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)

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.

Purposes

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
  • 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
Other Information (Other information)
  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°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
  • 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
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
Principal Display Panel 220 Mg Capsule Bottle Carton (PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton)

NDC 0363-0177-11

Walgreens

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

20 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

ACTUAL SIZE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)