SPL v3
SPL
SPL Set ID d9a0c6e7-a70e-479a-9737-e81a2887c778
Route
ORAL
Published
Effective Date 2023-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Blue No. 2 Magnesium Stearate Povidone Titanium Dioxide Starch, Corn Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: 17 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2019-01-16

Description

Active ingredient (in each caplet) Naproxen sodium 220mg (Naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer


Medication Information

Purpose

Pain reliever / fever reducer

Description

Active ingredient (in each caplet) Naproxen sodium 220mg (Naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces fever

Section 51945-4
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 NSAID, which may casue 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 everyday while using this product, take more or for a longer time than directed.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use:

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

Right before or after heart surgery 

Directions

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 caplet every 8 to 12 hours while symptoms last
  • For the first dose you may take 2 caplets within the first hour
  • Do not exceed 2 caplets in any 8 - 12 hour period
  • Do not exceed 3 caplets 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

Ask A Doctor

Ask a doctor before use if:

The stomach bleeding warning applies to you

You ahve 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

Ask a doctor or pharmacist before use if you are:

Under a doctor's care for any serious condition

Taking any other drugs

Inactive Ingredients

croscarmellose sodium, FD&C blue number 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

When Using This Product

When using this product:

Take with food or milk if stomach upset occurs. 

Stop Use and Ask A Doctor

Stop use and ask a doctor if:

You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, or 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

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 during the last 3 months of pregnancy unless definately 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 immediately (1-800-222-1222).

Active Ingredients (in Each Caplet)

Active ingredient (in each caplet)

Naproxen sodium 220mg

(Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses

Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces fever

Section 51945-4 (51945-4)
Purpose

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 NSAID, which may casue 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 everyday while using this product, take more or for a longer time than directed.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use:

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

Right before or after heart surgery 

Directions

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 caplet every 8 to 12 hours while symptoms last
  • For the first dose you may take 2 caplets within the first hour
  • Do not exceed 2 caplets in any 8 - 12 hour period
  • Do not exceed 3 caplets in a 24 hour period

Children under 12 years:ask a doctor

Do Not Use (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

Ask A Doctor (Ask a Doctor)

Ask a doctor before use if:

The stomach bleeding warning applies to you

You ahve 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

Ask a doctor or pharmacist before use if you are:

Under a doctor's care for any serious condition

Taking any other drugs

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue number 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

When Using This Product (When using this product)

When using this product:

Take with food or milk if stomach upset occurs. 

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if:

You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, or 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

If Pregnant Or Breast Feeding (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 during the last 3 months of pregnancy unless definately 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)



Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Active ingredient (in each caplet)

Naproxen sodium 220mg

(Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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