Giltuss Cough and Cold

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 Cough and Cold
Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
Gil Pharmaceutical Corp
Product type
HUMAN OTC DRUG
SPL set ID
8590fcc9-c0dd-f43b-e053-2991aa0a692e
SPL ID
5746a790-450c-79d7-e063-6394a90a7077
Version
8
Effective date
2026-07-23
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:14:59
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 more than the recommended dosage or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional. Ask a doctor before use if you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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