FDA Label for Back And Muscle Pain
View Indications, Usage & Precautions
Back And Muscle Pain Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Naproxen Sodium Tablets, USP
|
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
Purpose
Pain reliever/ fever reducer |
Indications & Usage
temporarily relieves minor aches and pain due to: backache
temporarily reduces fever |
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 to12 hours while symptoms last
for first dose you may take 2 tablets with in 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
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center right away. |
Warnings
Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening
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 bad stomach ulcers or bleeding problems
take blood thinning (anticoagulant) or steroid drug
take other drug 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: NSAID's, except aspirin, increases 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.
* Please review the disclaimer below.