Drug Labeling and Warnings
Drug Details [pdf]
NAPROXEN- naproxen sodium tablet
Zee Medical Inc
----------
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
| NAPROXEN
naproxen sodium tablet |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Zee Medical Inc (009645623) |
| Registrant - Zee Medical Inc (009645623) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ultraseal Corporation | 085752004 | pack(35418-000) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| SHASUN PHARMACEUTICALS LIMITED | 915786829 | manufacture(35418-000) | |