FDA label d78f5445-d50c-4e85-85b2-e781f199115d

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
de729638-8c7e-49e3-908c-de8820f3f60b
SPL ID
d78f5445-d50c-4e85-85b2-e781f199115d
Version
2
Effective date
2014-05-16
Source export date
2026-08-01
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:03:03

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Do not take this product for pain for more than 10 days (adults) or 5 days (children), and do not take for fever for more than 3 days unless directed by a physician. If pain of fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your physician. This preparation may cause drowsiness. Do not drive or operate machinery while taking this medication. Do not give to children under 6 years of age or exceed the recommended dosage unless directed by physician Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Information for Patients Patient consultation should include the following information regarding the proper use of this product: Do not exceed recommended dosage. May be taken with food or milk to lessen gastric irritation. Do not drive or operate heavy machinery if drowsiness or dizziness occurs. Concomitant use of alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers and anti-anxiety drugs) while taking this product may have an additive effect on drowsiness. If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Do not double the dose.