FDA.reportPublic FDA data

Guaifenesin, Dextromethorphan Hydrobromide Tablets

Manufacturer
InvaTech Pharma Solutions LLC | Elysium Pharmaceuticals Ltd
Effective date
2025-10-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:15:35

Label at a glance#

ProductGuaifenesin and Dextromethorphan Hydrobromide
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE SECTION

cough cold, allergic

WARNINGS SECTION

KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

INACTIVE INGREDIENT SECTION

Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN4
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD4
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57631-013-10Guaifenesin and Dextromethorphan Hydrobromide26500 in 1 BOXTABLET265004

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57631-01357631-013-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONE K30U725QWY32XIACT
HYPROMELLOSES3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsExact identifier
ndc (package): 57631-013-10
ndc (product): 57631-013
ndc11 (package): 57631001310
spl id: 402896d4-831f-c53d-e063-6294a90a21b3
spl set id: 40288ecf-043d-eb9e-e063-6394a90ac0a7

Reported adverse events (FAERS/openFDA)#

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