FDA label 571b157e-3198-4533-9b05-cf31bc1dbab9

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
2a2cd779-1c3e-445f-aa96-d02f9d4d91b7
SPL ID
571b157e-3198-4533-9b05-cf31bc1dbab9
Version
8
Effective date
2013-01-14
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:31

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 Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. Drug Dependence Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act. Usage in Ambulatory Patients Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient using the dihydrocodeine bitartrate, aspirin, and caffeine capsule should be cautioned accordingly. Interactions with other Central Nervous System Depressants Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with the dihydrocodeine bitartrate, aspirin, and caffeine capsule may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Usage in Pregnancy Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus. Usage in Children Preparations containing aspirin should be kept out of the reach of children. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is not recommended for patients 12 years of age and under. Since there is no experience in chil­dren who have received this drug, safety and efficacy in children have not been established.

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.