Amazon Basic Care-naproxen Sodium Casules, 220 Mg

Amazon Basic Care-naproxen Sodium Casules, 220 Mg
SPL v2
SPL
SPL Set ID 04a298dc-c525-8198-e063-6294a90a6f96
Route
ORAL
Published
Effective Date 2024-02-21
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 K30 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 2024-02-12

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

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 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.
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
  • slurred speech
  • weakness in one part or side of body
  • 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 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 right away.

Active Ingredients (in Each Capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 120's Bottle Label

Do not use if printed safety seal under cap is torn or missing.

***This product is not manufactured or distributed by the owners of ALEVE ® Liquid Gels.

DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109

© 2024 AMAZON.COM, INC.

OR ITS AFFILIATES.

ALL RIGHTS RESERVED.

P-03926

L0000731

R0623 Lot/Exp

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
Section 42229-5 (42229-5)

Drug Facts

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 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.
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
  • slurred speech
  • weakness in one part or side of body
  • 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 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 right away.

Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 120's Bottle Label (PRINCIPAL DISPLAY PANEL - 120's bottle label)

Do not use if printed safety seal under cap is torn or missing.

***This product is not manufactured or distributed by the owners of ALEVE ® Liquid Gels.

DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N.

SEATTLE, WA 98109

© 2024 AMAZON.COM, INC.

OR ITS AFFILIATES.

ALL RIGHTS RESERVED.

P-03926

L0000731

R0623 Lot/Exp

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)