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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Naproxen Sodium (NDC 67091-138). 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 other, active ingredient (in each caplet), purpose, uses, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID
nonsteroidal anti-inflammatory drug
)Pain reliever/fever reducer
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
| adults and children 12 years and older |
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| children under 12 years |
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croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST
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