Drug Facts
1b97ae91-7304-49f3-a5aa-38973bb61c49
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Naproxen sodium 220mg (naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
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
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 every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8-12 hour period do not exceed 3 tablets 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
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
Active Ingredient
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information
each tablet contains: sodium 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F). Do not use if tamper evident seal under bottle cap is broken or missing.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
When Using This Product
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
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, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma
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 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
ask a health professional before use. It is especially important not to use naproxen sodium during the
last 3 months of 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 immediately
Package/label Principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You Are
under a doctors care for any serious condition ■ taking any other 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
Purpose
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■ Adults and children 12 years and older: ■ take 1 tablet every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8-12 hour period do not exceed 3 tablets 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
Allergy Alert (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
Active Ingredient (Active ingredient)
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information
each tablet contains: sodium 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F). Do not use if tamper evident seal under bottle cap is broken or missing.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
When Using This Product (When using this product)
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stomach Bleeding Warning (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
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, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma
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 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 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 immediately
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
under a doctors care for any serious condition ■ taking any other drug
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:52.935066 · Updated: 2026-03-14T22:53:54.250290