FDA label 8cff6946-2b0e-4f86-815d-c73cd77b45d5

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
f147ebbb-fb5c-4edb-9c67-6b358b9389e0
SPL ID
8cff6946-2b0e-4f86-815d-c73cd77b45d5
Version
2
Effective date
2020-04-07
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:20

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 exceed recommended dosage. As k a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease, high blood pressure, thyroid disease, diabetes, glaucoma a persistent or chronic cough such occurs with smoking, asthma a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland. Ask a doctor before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a more serious condition. if new symptoms occur These can be signs of a serious condition. If pregnant or breastfeeding, ask a health professional before use. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage .

Reported adverse events (FAERS/openFDA)#

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