Chlo Hist

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)

Brand name
Chlo Hist
Generic name
CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE
Manufacturer
R. A. McNeil Company
Product type
HUMAN OTC DRUG
SPL set ID
d046f4ba-5753-4ed5-a924-0b66fd116781
SPL ID
413d8eeb-e320-427b-e063-6394a90a9fe4
Version
13
Effective date
2025-10-15
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:16:49
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when diving a motor vehicle or operating machinery. Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma 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 excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizes may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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