Guaifenesin 400

Manufacturer: InvaTech Pharma Solutions LLC | Elysium Pharmaceuticals Ltd
Effective date: 2025-10-02
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:15:35

Label at a glance#

ProductGuaifenesin 400

Active ingredientGUAIFENESIN

Label structure3 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

cough, cold

INACTIVE INGREDIENT SECTION

Calcium sennosides 20% IH, Colloidal Silicon Di oxide USP/NF, Croscarmellose sodium USP/NF, Crospovidone [Kollidon] USP/NF, Dicalcium phosphate/ dibasic calcium phosphate [DIREC] USP/NF, Filmcoat AMB-51D0393632-Blue lake IH, Magnesium stearate. USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Sodium lauryl sulfate USP/NF, Stearic acid powder USP/NF, Purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sennosides Tablets USP, 25 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

guaifenesin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	5
359601	guaifenesin 400 MG Oral Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57631-012-00	Guaifenesin 400	28000 in 1 BOX	TABLET	28000		5

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Guaifenesin 400
Guaifenesin Tablets 400
STEARIC ACID
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A
POVIDONE K30
MICROCRYSTALLINE CELLULOSE
MALTODEXTRIN
SILICON DIOXIDE
GUAIFENESIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57631-012	57631-012-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STEARIC ACID	4ELV7Z65AP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
POVIDONE K30	U725QWY32X	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
GUAIFENESIN	495W7451VQ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier ndc (package): 57631-012-00 ndc (product): 57631-012 ndc11 (package): 57631001200 spl id: 4029150e-7782-a118-e063-6294a90a09c1 spl set id: 40291505-55ca-0759-e063-6394a90acee1

Reported adverse events (FAERS/openFDA)#

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