Drug Facts
043f7032-4e83-4642-93a8-6c09de26b43f
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
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Naproxen sodium 220 mg (naproxen 200 mg) (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
Purposes
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke: 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.
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
- adults and children 12 years and older:
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules 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
Product Label
Other Information
- each capsule contains: sodium 20 mg
- store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
- read all directions and warnings before use. Keep carton.
- swallow whole; do not crush, chew, or dissolve
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the Active Ingredient in Aleve®†
NAPROXEN SODIUM
Capsules, 220 mg
Pain Reliever; Fever Reducer (NSAID)
Strength to lasts 12 hours
CAPSULES**
**Liquid-Filled Capsules
†This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
©2018 S&S Brands, LLC
When Using This Product
take with food or milk if stomach upset occurs
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
Stop Use and Ask A Doctor If
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
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 right away.(1-800-222-1222).
Active Ingredient (in Each Capsule)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Ask A Doctor Or Pharmacist Before Use If You Are
- under a doctor’s 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
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
Purposes
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke: 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.
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
- adults and children 12 years and older:
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules 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
Product Label
Other Information (Other information)
- each capsule contains: sodium 20 mg
- store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
- read all directions and warnings before use. Keep carton.
- swallow whole; do not crush, chew, or dissolve
Inactive Ingredients (Inactive ingredients)
FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the Active Ingredient in Aleve®†
NAPROXEN SODIUM
Capsules, 220 mg
Pain Reliever; Fever Reducer (NSAID)
Strength to lasts 12 hours
CAPSULES**
**Liquid-Filled Capsules
†This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
©2018 S&S Brands, LLC
When Using This Product (When using this product)
take with food or milk if stomach upset occurs
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, 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
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
- have bloody or black stools
- vomit blood
- 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
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. (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).
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
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 any other drug
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:22.959173 · Updated: 2026-03-14T23:00:47.249871