Active Ingredient
Naproxen Sodium Tablets, USP
|
Back And Muscle Pain Tablet, Coated
FDA Label NDC 0363-9609
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Back And Muscle Pain (NDC 0363-9609). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredients, purpose, indications & usage, directions, otc - keep out of reach of children, warnings, 24 ct, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
