childrens cold and cough

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
childrens cold and cough
Generic name
BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
HyVee Inc
Product type
HUMAN OTC DRUG
SPL set ID
686f43ea-4296-4eee-b762-9a9e68344340
SPL ID
cdcae3a3-70df-4737-a6f3-9d4c1f4ff524
Version
2
Effective date
2026-03-26
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:06:21
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 use • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • may cause marked drowsiness • 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 Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. 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 (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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