Naproxen Sodium 220mg
91e1fef2-0e9b-4553-92f2-ddf219990695
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
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
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
- 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 to 12 hour period
- do not exceed 3 caplets 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
Active Ingredient
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information
- each caplet contains: sodium 20 mg
- 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
croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide
Questions Or Comments?
Call1-800-326-8147
Principal Display Panel
NAPROXEN
SODIUM
(NSAID*)
MODERN PAIN MEDICINE
PAIN & FEVER RELIEF
CONTAINS NO ASPIRIN
CAFFEINE FREE
Compare to Aleve®*
SEE NEW WARNINGS INFORMATION
50 Caplets
220 mg Each
When Using This Product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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, 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
- You may report side effects to 1-888-952-0050
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 (1-800-222-1222) right away.
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.
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
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 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
- 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 to 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
Active Ingredient (Active ingredient)
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information (Other information)
- each caplet contains: sodium 20 mg
- 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 (Inactive ingredients)
croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide
Questions Or Comments? (Questions or Comments?)
Call1-800-326-8147
Principal Display Panel
NAPROXEN
SODIUM
(NSAID*)
MODERN PAIN MEDICINE
PAIN & FEVER RELIEF
CONTAINS NO ASPIRIN
CAFFEINE FREE
Compare to Aleve®*
SEE NEW WARNINGS INFORMATION
50 Caplets
220 mg Each
When Using This Product (When using this product)
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Ask A Doctor Before Use If (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, 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
- You may report side effects to 1-888-952-0050
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 (1-800-222-1222) right away.
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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:59:31.579836 · Updated: 2026-03-14T22:59:32.588894