Naproxen Sodium
605ca130-88aa-27d5-330c-6d9c95987f1f
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
Headache
Headache Container Label:
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).
Back and Muscle Pain
Back and Muscle Pain- Container
Inactive Ingredients
FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Otc Stop Use Section
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
Questions Or Comments?
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Otc Do Not Use Section
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
Otc When Using Section
When using this product
take with food or milk if stomach upset occurs
Spl Unclassified Section
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.
Otc Ask A Doctor Section
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
Otc Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are
under a doctor's care for any serious condition
taking any other drug
Active Ingredient (in Each Tablet/caplet)
Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)
Otc Pregnancy Or Breast Feeding Section
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.
Otc Keep Out of Reach of Children Section
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).
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
Headache
Headache Container Label:
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).
Back and Muscle Pain
Back and Muscle Pain- Container
Inactive Ingredients (Inactive ingredients)
FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
Otc Stop Use Section (OTC - STOP USE SECTION)
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
Questions Or Comments? (Questions or comments?)
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Otc Do Not Use Section (OTC- DO NOT USE SECTION)
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
Otc When Using Section (OTC - WHEN USING SECTION)
When using this product
take with food or milk if stomach upset occurs
Spl Unclassified Section (SPL UNCLASSIFIED SECTION)
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.
Otc Ask A Doctor Section (OTC- ASK A DOCTOR SECTION)
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
Otc Ask Doctor/pharmacist Section (OTC - ASK DOCTOR/PHARMACIST SECTION)
Ask a doctor or pharmacist before use if you are
under a doctor's care for any serious condition
taking any other drug
Active Ingredient (in Each Tablet/caplet) (Active ingredient (in each tablet/caplet))
Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)
Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)
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.
Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)
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).
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:35.818284 · Updated: 2026-03-14T23:09:28.158875