Daytime and Nighttime Cough and Chest Congestion Childrens

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
Daytime and Nighttime Cough and Chest Congestion Childrens
Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE
Manufacturer
CVS Pharmacy
Product type
HUMAN OTC DRUG
SPL set ID
347f1731-5b85-4220-ae2b-9497a3afa4ed
SPL ID
a7615299-bda6-4721-b887-2ee4d4b299ae
Version
7
Effective date
2026-08-19
Source export date
2026-10-12
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:13:37

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 Do not us DAYTIME • 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. NIGHTTIME • to sedate a child or to make a child sleepy • 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. Ask a doctor before use if you have DAYTIME • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema NIGHTTIME • trouble urinating due to an enlarges prostate gland • glaucoma • a cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are NIGHTTIME taking sedatives or tranquilizers. When using this product NIGHTTIME • do not use more than directed. • marked drowsiness may occur • avoid alcoholic drinks • 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 DAYTIME • cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. NIGHTTIME • cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, DAYTIME ask a health professional before use. NIGHTTIME ask a health professional before use Keep out of reach of children. DAYTIME In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. NIGHTTIME In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Reported adverse events (FAERS/openFDA)#

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