Desinflamax - Naproxen Sodium

Manufacturer
OPMX LLC | Granules India Limited
Effective date
2023-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:29:13

Label at a glance#

ProductDesinflamax - Naproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure9 sections

Indications and uses

■ temporarily relieves minor aches and pains due to: ■ headache ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever

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 Adults and children 12 years and older: ■ take 1 tablet every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8 to12 hour period ■ do not exceed 3 tablets in a 24 hour period Children under 12 years ■ ask a do...

Storage and handling

■ each tablet contains: sodium 20 mg ■ store at 20-25° C (68-77° F). Avoid high humidity and excessive heat above 40° C (104° F) ■ read all product information before using ■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet) Purposes

Naproxen Sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves minor aches and pains due to:

■ headache ■ backache ■ muscular aches

■ the common cold ■ toothache ■ menstrual cramps

■ minor pain of arthritis ■ temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ asthma (wheezing) ■ skin reddening

■ facial swelling ■ shock ■ rash ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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, or kidney disease

■ you are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ under a doctor's care for any serious condition

■ taking any other drug

When using this product

OTC - WHEN USING SECTION

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

■ 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

■ 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

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 during the last 3 months of 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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:

■ take 1 tablet every 8 to 12 hours while symptoms last

■ for the first dose you may take 2 tablets within the first hour

■ do not exceed 2 tablets in any 8 to12 hour period

■ do not exceed 3 tablets in a 24 hour period

Children under 12 years

■ ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: sodium 20 mg

■ store at 20-25° C (68-77° F). Avoid high humidity and excessive heat above 40° C (104° F)

■ read all product information before using

■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or www.opmx.us

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-032-24

Desinflamax Naproxen Sodium

220mg

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

24 Caplets

Naproxen Desinflamax 24 CapletsNaproxen Desinflamax 24 Caplets

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-03269729-032-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
155c8126-5d30-9b66-e063-6394a90aea06ff664276-6b74-2840-e053-6394a90adbbf2024-04-05WarningsExact identifier
spl set id: ff664276-6b74-2840-e053-6394a90adbbf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.