Naproxen Sodium
12e45b43-eca2-73f4-1d68-07d4238f8c70
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 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
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 50570-1
Do not use
- If you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51945-4
Headache Pain - Caplet 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
Headache Pain - Caplet 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 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
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 50570-1 (50570-1)
Do not use
- If you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51945-4 (51945-4)
Headache Pain - Caplet 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)
Headache Pain - Caplet Container
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:13.257325 · Updated: 2026-03-14T23:08:52.632356