Principal Display Panel
b54250d5-edcc-450a-9b87-d7bdb5fc301b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Medication Information
Warnings and Precautions
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening shock blisters rash facial swelling hives 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 have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk 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.
Indications and Usage
temporarily relieves minor aches and pains due to: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis temporarily reduces fever
Dosage and Administration
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- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor
Description
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Section 44425-7
each tablet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number
Section 50565-1
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
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 slurred speech leg swelling trouble breathing weakness in one part or side of body 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
take with food or milk if stomach upset occurs
Section 50568-5
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
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
if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
Section 51727-6
croscarmellose sodium, FD & C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Section 51945-4
equate™ NDC 79903-098-52 Compare to Aleve® Back & Muscle Pain Tablets active ingredient** All Day Back & Muscle Pain Relief Naproxen Sodium Tablets, 220 mg Pain Reliever/ Fever Reducer (NSAID) • For temporary relief of minor back and muscle aches and pains Actual Size STRENGTH TO LAST 12 HOURS 220 mg EACH 90 TABLETS Package Contains One Bottle Actual Size TAMPER EVIDENT: DO NOT USE IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PRODUCT OF CHINA AND INDIA **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Back & Muscle Pain Tablets. 50844 REV1221A41752 Equate 44-417BM
Section 53413-1
1-888-287-1915
Section 53414-9
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.
Section 55105-1
Pain reliever/fever reducer
Section 55106-9
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Structured Label Content
Indications and Usage (34067-9)
temporarily relieves minor aches and pains due to: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis temporarily reduces fever
Dosage and Administration (34068-7)
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- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor
Warnings and Precautions (34071-1)
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) skin reddening shock blisters rash facial swelling hives 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 have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk 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.
Section 44425-7 (44425-7)
each tablet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number
Section 50565-1 (50565-1)
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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 slurred speech leg swelling trouble breathing weakness in one part or side of body 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)
take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
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)
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)
if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
Section 51727-6 (51727-6)
croscarmellose sodium, FD & C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Section 51945-4 (51945-4)
equate™ NDC 79903-098-52 Compare to Aleve® Back & Muscle Pain Tablets active ingredient** All Day Back & Muscle Pain Relief Naproxen Sodium Tablets, 220 mg Pain Reliever/ Fever Reducer (NSAID) • For temporary relief of minor back and muscle aches and pains Actual Size STRENGTH TO LAST 12 HOURS 220 mg EACH 90 TABLETS Package Contains One Bottle Actual Size TAMPER EVIDENT: DO NOT USE IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PRODUCT OF CHINA AND INDIA **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve® Back & Muscle Pain Tablets. 50844 REV1221A41752 Equate 44-417BM
Section 53413-1 (53413-1)
1-888-287-1915
Section 53414-9 (53414-9)
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.
Section 55105-1 (55105-1)
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:09.322410 · Updated: 2026-02-15T12:06:09.297760