Naproxen Tablet
FDA Label NDC 68071-4006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Naproxen (NDC 68071-4006). 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 how supplied, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

How Supplied

NAPROXEN TABLETS

500 MG: WHITE TO OFF-WHITE, CAPSULE-SHAPED TABLETS WITH “140” DEBOSSED ON ONE SIDE AND SCORED ON

OTHER SIDE.

NDC 68071-4006-1 Bottles of 10

NDC 68071-4006-7 Bottles of 14

NDC 68071-4006-5 Bottles of 15

NDC 68071-4006-2 Bottles of 20

NDC 68071-4006-3 Bottles of 30

NDC 68071-4006-4 Bottles of 40

NDC 68071-4006-6 Bottles of 60

NDC 68071-4006-9 Bottles of 90

STORE AT 20°-25°C (68°-77°F) EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F) IN WELL-CLOSED CONTAINERS

[SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN LIGHT-RESISTANT CONTAINERS.

RX ONLY

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