Guaifenesin DM

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
Guaifenesin DM
Generic name
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
ac8c0c15-b305-47f2-8712-e4b53636f7fa
SPL ID
06c3176d-e6f9-4231-e063-6394a90a694b
Version
9
Effective date
2023-10-02
Source export date
2026-10-27
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/55ffdfed5c29f1b4aed512886bd3fb7831e157cc4948137779971a558752ed2b/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:08:13
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product. Ask a doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occure with fever, rash or persistent headache These could be signs of serious illness. 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). Directions take with a full glass of water this product can be administered without regard for the timing of meals do not exceed 6 doses in 24 hours or as directed by doctor adults and children 12 years of age and over take 1 tablet every 4 hours as needed children 6 to under 12 years of age take ½ tablet every 4 hours as needed children under 6 years of age consult a doctor

warnings table

<table width="50%" border="1" cellspacing="0" cellpadding="0"><tbody><tr><td valign="top"><paragraph>adults and children 12 years of age and over</paragraph></td><td valign="top"><paragraph>take 1 tablet every 4 hours as needed</paragraph></td></tr><tr><td valign="top"><paragraph>children 6 to under 12 years of age</paragraph></td><td valign="top"><paragraph>take &#xBD; tablet every 4 hours as needed</paragraph></td></tr><tr><td valign="top"><paragraph>children under 6 years of age</paragraph></td><td valign="top"><paragraph>consult a doctor</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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