Skip to Content

← See all Naproxen brands

Naproxen by Zee Medical Inc

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Zee Medical Inc
NDC Code: 35418-000

Uses

temporarily relieves minor aches and pains due to:

headache ■ common cold ■ muscular aches

backache ■ toothache ■ menstrual cramps

minor pain of arthritis

temporarily reduces fever

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.

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

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 ■ blisters ■ rash

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

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

the stomach bleeding warning applies to you

you have a history of stomach problems, such as

heartburn

you have problems or serious side effects

from taking pain relievers or fever reducers

you have high blood pressure, heart disease,

liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if

you are

under a doctor's care for any serious

condition

taking any other drug

When using this product

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

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

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:

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 to 12-hour

period

do not exceed 3 tablets in a 24-hour period

children under 12 years: ask a doctor

Inactive ingredients

colloidal silicon dioxide, croscarmellose

sodium, FD&C blue #2 lake, hypromellose,

magnesium stearate, microcrystalline

cellulose, polyethylene glycol, povidone,

titanium dioxide

ACTIVE INGREDIENT-NAPROXEN SODIUM 220 MG

(NSAID) PAIN RELIEVER/FEVER REDUCER

NAPROXEN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-000
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 2 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-000-6850 PACKET in 1 CARTON
1NDC:35418-000-161 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/31/2015
Labeler - Zee Medical Inc (009645623)
Registrant - Zee Medical Inc (009645623)
Establishment
NameAddressID/FEIOperations
Ultraseal Corporation085752004pack(35418-000)
Establishment
NameAddressID/FEIOperations
SHASUN PHARMACEUTICALS LIMITED915786829manufacture(35418-000)

 
Zee Medical Inc

← See all Naproxen brands

Medically reviewed on May 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide