Giltuss Childrens Cough and Chest Congestion

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
Giltuss Childrens Cough and Chest Congestion
Generic name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Manufacturer
Gil Pharmaceutical Corp
Product type
HUMAN OTC DRUG
SPL set ID
852d5f01-9289-5515-e053-2a91aa0acf32
SPL ID
40b83871-7eac-3d44-e063-6394a90a2b29
Version
6
Effective date
2025-10-09
Source export date
2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:29
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 your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma Stop use and ask a doctor or pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever cough comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. When using this product do not use more than directed. 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.