PHARBINEX-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
PHARBINEX-DM
Generic name
GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG
Manufacturer
Pharbest Pharmaceuticals, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
8d71db43-da87-45ee-aa4a-7e870bc5016d
SPL ID
fcbabd90-abc6-4a05-8841-58cb74b5a22e
Version
3
Effective date
2025-12-24
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/3744b3ae389d13e8f30cade845ea29e0fc75bb043dcda980c2025693f0c10522/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 09:08:12
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. 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. Directions take with a full glass of water do not exceed 6 doses in 24 hours 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.