FDA label fd8f156a-ee8a-e3e0-e053-6394a90a87fc

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
c6a42780-9977-708f-e053-2a95a90a07e6
SPL ID
fd8f156a-ee8a-e3e0-e053-6394a90a87fc
Version
2
Effective date
2023-06-07
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:27:26

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 Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.