Naproxen Sodium 

Naproxen Sodium 
SPL v6
SPL
SPL Set ID 605ca130-88aa-27d5-330c-6d9c95987f1f
Route
ORAL
Published
Effective Date 2021-06-04
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 2021-08-05

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

Headache

Headache Container Label:

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).
Back and Muscle Pain

Back and Muscle Pain- Container

Inactive Ingredients

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

Otc Stop Use Section

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 

Questions Or Comments?

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

Otc Do Not Use Section

Do not use 

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery 

Otc When Using Section

When using this product

take with food or milk if stomach upset occurs

Spl Unclassified Section

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.

Otc Ask A Doctor Section

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

Otc Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you are 

under a doctor's care for any serious condition

taking any other drug 

Active Ingredient (in Each Tablet/caplet)

Naproxen sodium USP, 220 mg

(naproxen USP, 200 mg) (NSAID)

nonsteroidal anti-inflammatory drug

Otc Pregnancy Or Breast Feeding Section

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.

Otc Keep Out of Reach of Children Section

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).


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

Headache

Headache Container Label:

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).
Back and Muscle Pain

Back and Muscle Pain- Container

Inactive Ingredients (Inactive ingredients)

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

Otc Stop Use Section (OTC - STOP USE SECTION)

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 

Questions Or Comments? (Questions or comments?)

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

Otc Do Not Use Section (OTC- DO NOT USE SECTION)

Do not use 

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery 

Otc When Using Section (OTC - WHEN USING SECTION)

When using this product

take with food or milk if stomach upset occurs

Spl Unclassified Section (SPL UNCLASSIFIED SECTION)

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.

Otc Ask A Doctor Section (OTC- ASK A DOCTOR SECTION)

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

Otc Ask Doctor/pharmacist Section (OTC - ASK DOCTOR/PHARMACIST SECTION)

Ask a doctor or pharmacist before use if you are 

under a doctor's care for any serious condition

taking any other drug 

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

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

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).


Advanced Ingredient Data


Raw Label Data

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