Active Ingredient (In Each Tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Back And Muscle Pain (NDC 36800-696). 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 (in each tablet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
Heart attack and stroke warning: NSAIDs, except aspirin, increase 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
take with food or milk if stomach upset occurs
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Adults and children 12 years and older |
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Children under 12 years |
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FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
1-888-423-0139
COMPARE TO ALEVE® BACK & MUSCLE PAIN ACTIVE INGREDIENT
Back & Muscle Pain
NAPROXEN SODIUM TABLETS, 220 mg EACH
PAIN RELIEVER – FEVER REDUCER (NSAID)
For temporary relief of minor back and muscle aches and pains
OUR PHARMACISTS RECOMMEND
12 HOUR
Strength to last 12 hours
100 TABLETS
actual size
* Please review the disclaimer below.