1145-res-2025-0617
5ea3217d-845d-4781-b849-6b00babdc214
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:
- minor pain of arthritis
- muscular aches
- backache
- 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. (1-800-822-1222)
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
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 |
|
| 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
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.
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).
Inactive Ingredients
croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
Questions Or Comments?
1-844-705-4384
Principal Display Panel
RESTOREU
NDC 57344-145-01
†COMPARE TO THE ACTIVE INGREDIENT IN ALEVE®
Naproxen Sodium
Tablets, 220 mg
Pain Reliever/Fever Reducer
(NSAID)
Strength to last 12 hours
actual size
24 CAPLETS**
**CAPSULE-SHAPED TABLETS
When Using This Product
- take with food or milk if stomach upset occurs
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
- 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
■ 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
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.
Active Ingredient (in Each Caplet)
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 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
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. (1-800-822-1222)
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
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 |
|
| 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
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.
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).
Inactive Ingredients (Inactive ingredients)
croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-844-705-4384
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
RESTOREU
NDC 57344-145-01
†COMPARE TO THE ACTIVE INGREDIENT IN ALEVE®
Naproxen Sodium
Tablets, 220 mg
Pain Reliever/Fever Reducer
(NSAID)
Strength to last 12 hours
actual size
24 CAPLETS**
**CAPSULE-SHAPED TABLETS
When Using This Product (When using this product)
- take with food or milk if stomach upset occurs
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)
- 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
■ 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
Heart Attack and Stroke Warning (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.
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
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 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: 2026-02-15T12:06:19.714023 · Updated: 2026-03-14T23:09:03.764166