FDA label 8f082c11-0ef2-40fe-9a49-2ee02bd8a9b5

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
cd33f3ef-8e30-441f-9deb-0c03e5e67951
SPL ID
8f082c11-0ef2-40fe-9a49-2ee02bd8a9b5
Version
3
Effective date
2015-05-05
Source export date
2026-08-17
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/28baf16af715ee15453297f68cf3645a4d0fd0920220426fbe9d0c3d228bd86d/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:23:19

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 a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis, ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Directions ■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ adults and children 12 years and over: 1 tablet ■ children 6 to under 12 years: 1/2 tablet ■ children under 6 years: consult a doctor Other information ■ save carton for full directions and warnings ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients D.&C. Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.