Naproxen Sodium 

Naproxen Sodium 
SPL v6
SPL
SPL Set ID 12e45b43-eca2-73f4-1d68-07d4238f8c70
Route
ORAL
Published
Effective Date 2022-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Povidone Talc Titanium Dioxide Polysorbate 80

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-12-10

Description

PAIN RELIEVER / FEVER REDUCER (NSAID) Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

PAIN RELIEVER / FEVER REDUCER (NSAID) 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

PAIN RELIEVER / FEVER REDUCER (NSAID)

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 50566-9

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 pill is stuck in your throat
  • redness or swelling is present in the painful area 
  • any new symptoms appear

Section 50567-7

When using this product

  • take with food or milk if stomach upset occurs

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Section 51945-4

Headache Pain - Caplet Carton

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

Warnings

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/caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets/caplets within the first hour
  • do not exceed 2 tablets/caplets in any 8 to 12 hour period
  • do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years
  • ask a doctor
Other Information
  • each tablet/caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive Ingredients

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions Or Comments?

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Active Ingredient (in Each Tablet/caplet)

Naproxen sodium USP, 220 mg

(naproxen USP, 200 mg) (NSAID)

nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel Section

Headache Pain - Caplet Container


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)

PAIN RELIEVER / FEVER REDUCER (NSAID)

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 50566-9 (50566-9)

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 pill is stuck in your throat
  • redness or swelling is present in the painful area 
  • any new symptoms appear

Section 50567-7 (50567-7)

When using this product

  • take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Section 51945-4 (51945-4)

Headache Pain - Caplet Carton

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

Warnings

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/caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets/caplets within the first hour
  • do not exceed 2 tablets/caplets in any 8 to 12 hour period
  • do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years
  • ask a doctor
Other Information (Other information)
  • each tablet/caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive Ingredients (Inactive ingredients)

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Active Ingredient (in Each Tablet/caplet) (Active ingredient (in each tablet/caplet))

Naproxen sodium USP, 220 mg

(naproxen USP, 200 mg) (NSAID)

nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel Section (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION)

Headache Pain - Caplet Container


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)