Naproxen Sodium
aca5d497-fbc6-464d-2dee-25c50e11bc78
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
PAIN RELIEVER / FEVER REDUCER (NSAID) Drug Facts
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
PAIN RELIEVER / FEVER REDUCER (NSAID) 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
PAIN RELIEVER / FEVER REDUCER (NSAID)
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 (1-800-222-1222).
Section 50566-9
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 paint
- 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
Section 50567-7
When using this product
- take with food or milk if stomach upset occurs
Section 50568-5
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
Section 50569-3
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
Section 51945-4
Container Carton
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
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 |
|
Other Information
- each tablet/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
FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions Or Comments?
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Active Ingredient (in Each Tablet/caplet)
Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)
Package Label.principal Display Panel Section
Caplets
Container
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)
PAIN RELIEVER / FEVER REDUCER (NSAID)
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 (1-800-222-1222).
Section 50566-9 (50566-9)
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 paint
- 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
Section 50567-7 (50567-7)
When using this product
- take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
Section 51945-4 (51945-4)
Container Carton
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
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 |
|
Other Information (Other information)
- each tablet/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)
FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Active Ingredient (in Each Tablet/caplet) (Active ingredient (in each tablet/caplet))
Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)
Package Label.principal Display Panel Section (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION)
Caplets
Container
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:14.222719 · Updated: 2026-03-14T23:08:54.445441