Indications and 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
Naproxen Sodium Capsules, 220 mg, liquid filled
- Manufacturer
- Strides Pharma Inc | Strides Pharma Global Pte. Ltd. | Strides Pharma Science Limited
- Effective date
- 2025-01-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:43:01
Label at a glance#
ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure11 sections
Dosage and administration
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: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a ...
Storage and handling
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.
Contacts and useful links#
Websitewww.strides.com
www.strides.com
www.strides.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient (in each capsule)
Naproxen sodium, 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
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
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
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.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- 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
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
When using this product
- take with food or milk if stomach upset occurs
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
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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: |
|
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 [racemic] [DM], polythene glycol 600, povidone-K-30, propylene glycol, purified water, sorbitol sorbitan solution.
printing ink white-edible oil - dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.
Questions or comments?
go to www.strides.com or call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825
SPL UNCLASSIFIED SECTION
Manufactured by:
Strides Pharma Science Limited
Bengaluru-562106, India.
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Do not use if printed safety seal under cap is torn or missing.
***This product is not manufactured or distributed by the owners of ALEVE® Liquid Gels.
***compare to the active ingredient in ALEVE® Liquid Gels
Issued: 06/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Naproxen Sodium
- NAPROXEN
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- ISOPROPYL ALCOHOL
- LACTIC ACID
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYETHYLENE GLYCOL 600
- POVIDONE K30
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59556-117 | 59556-117-02, 59556-117-03, 59556-117-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 91970268-fe9f-42fd-8ed3-cd1121b0d14e | 4a4aed07-79a4-49e3-aff3-bbec61622451 | 2025-01-10 | Warnings | 91970268-fe9f-42fd-8ed3-cd1121b0d14e 4a4aed07-79a4-49e3-aff3-bbec61622451 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.