FDA label 45541858-1e5c-4166-bee1-456a37c295d0

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
78dff3f7-0680-4a7a-995d-2971a70a2936
SPL ID
45541858-1e5c-4166-bee1-456a37c295d0
Version
2
Effective date
2016-11-09
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:00

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: In case of overdose, get medical help or contact a Poison Control Center right away. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. A persistent cough or high fever may be the sign of a serious health condition. If fever persists for more than 3 days, consult a physician. If cough persists for more than one week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a physician. Do not take this product for consistent or chronic cough such as occurs with smoking, asthma, or emphysema, of if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a health care professional before using this product. Keep this and all medicines out of the reach of children. Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number. STORE IN A COOL, DRY PLACE Contains milk.

Reported adverse events (FAERS/openFDA)#

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