ba4f927a-4bbe-0d87-e053-2995a90a8c20
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Drug Facts
Uses
- temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- minor pain of arthritis
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding,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.
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
- 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
- if taken with food, this product may take longer to work
| adults and children 12 years and older: |
|
| children under 12 years: |
|
Do Not Use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
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)
- protect from light
- read all directions and warnings before use.
Inactive Ingredients
FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions Or Comments?
1-888-235-2466(Mon - Fri 9AM - 5PM EST)
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
- 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
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
Active Ingredient (in Each Capsule)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Principal Display Panel 180's Bottle
*** compare tothe active ingredient in ALEVE® Liquid Gels
a+health
naproxen sodium capsules, 220 mg
(NSAID)
pain reliever/fever reducer
strength to last 12 hours
180 capsules**
**liquid-filled capsule
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:
- backache
- muscular aches
- minor pain of arthritis
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding,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.
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
- 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
- if taken with food, this product may take longer to work
| adults and children 12 years and older: |
|
| children under 12 years: |
|
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
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)
- protect from light
- read all directions and warnings before use.
Inactive Ingredients (Inactive ingredients)
FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions Or Comments? (Questions or comments?)
1-888-235-2466(Mon - Fri 9AM - 5PM EST)
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
- 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
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Principal Display Panel 180's Bottle (PRINCIPAL DISPLAY PANEL - 180's Bottle)
*** compare tothe active ingredient in ALEVE® Liquid Gels
a+health
naproxen sodium capsules, 220 mg
(NSAID)
pain reliever/fever reducer
strength to last 12 hours
180 capsules**
**liquid-filled capsule
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:35.479927 · Updated: 2026-03-14T23:02:15.001245