GUAIFENESIN

Manufacturer: PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date: 2022-06-14
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:36:43

Label at a glance#

ProductGUAIFENESIN

Active ingredientGUAIFENESIN

Label structure13 sections

Indications and uses

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Dosage and administration

Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician

Storage and handling

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Expectorant
SUGAR FREE / ALCOHOL FREE

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

Sodium Content: 4 mg/5 mL

USES

INDICATIONS & USAGE SECTION

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
you are hypersensitive to any of the ingredients.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Professional Note

SPL UNCLASSIFIED SECTION

Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Follow dosage below or use as directed by a physician.

do not take more than 6 doses in any 24-hour period.

age	dose
adults and children 12 years and over	10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age	2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours
children under 2 years of age	consult a physician

HOW SUPPLIED SECTION

Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

NDC 0121-0744-04: 4 fl oz (120 mL) bottle
NDC 0121-0744-08: 8 fl oz (237 mL) bottle
NDC 0121-0744-16: 16 fl oz (473 mL) bottle

NDC 0121-1744-05: 5 mL unit dose cup
NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-1488-10: 10 mL unit dose cup
NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

NDC 0121-2232-15: 15 mL unit dose cup
NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

STORAGE

STORAGE AND HANDLING SECTION

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-0744-16

Quality ^®
Value

Guaifenesin Oral Solution USP

100 mg/5 mL

EXPECTORANT

Compare to the
active ingredient in
*Robitussin®

SUGAR FREE/ALCOHOL FREE
LOOSENS AND RELIEVES
CHEST CONGESTION

16 fl oz (473 mL)

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-1744-05

G UAIFENESIN O RAL S OLUTION USP

100 mg/5 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1488-10

G UAIFENESIN O RAL S OLUTION USP

200 mg/10 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 15 mL

NDC 0121-2232-15

G UAIFENESIN O RAL S OLUTION USP

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	9
310604	guaifenesin 20 MG/ML Oral Solution	SCD	9
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	9
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	9
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	9
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	9
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	9

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	SPL version
0121-0744-04	GUAIFENESIN	118 mL in 1 BOTTLE	SOLUTION	118	9
0121-0744-08	GUAIFENESIN	237 mL in 1 BOTTLE	SOLUTION	237	9
0121-0744-16	GUAIFENESIN	473 mL in 1 BOTTLE	SOLUTION	473	9
0121-1488-00	GUAIFENESIN	10 in 1 TRAY	SOLUTION	10	9
0121-1488-00	GUAIFENESIN	10 in 1 CASE	SOLUTION	10	9
0121-1488-10	GUAIFENESIN	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	9
0121-1744-00	GUAIFENESIN	10 in 1 CASE	SOLUTION	10	9
0121-1744-00	GUAIFENESIN	10 in 1 TRAY	SOLUTION	10	9
0121-1744-05	GUAIFENESIN	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	9
0121-2232-00	GUAIFENESIN	10 in 1 TRAY	SOLUTION	10	9
0121-2232-00	GUAIFENESIN	10 in 1 CASE	SOLUTION	10	9
0121-2232-15	GUAIFENESIN	15 mL in 1 CUP, UNIT-DOSE	SOLUTION	15	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0744	GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	9	Current NDC, Legacy NDC, 3 package rows	20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.zip
0121-1488	GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	9	Current NDC, Legacy NDC, 3 package rows	20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.zip
0121-1744	GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	9	Current NDC, Legacy NDC, 3 package rows	20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.zip
0121-2232	GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	9	Current NDC, Legacy NDC, 3 package rows	20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1744-00	ML - Milliliter	0121-1744	171bdc6a-7b5f-45a7-87e1-b202b3ef5ad4	1	2018-01-12
0121-1744-05	ML - Milliliter	0121-1744	80ee20cf-4e2b-4882-bcd2-cbd2ec3f4671	1	2014-10-03
0121-1744-10	ML - Milliliter	0121-1744	29730dba-fb62-49e5-b8f8-98345a3002ea	1	2014-10-03
0121-1744-15	ML - Milliliter	0121-1744	8868bbf3-ee16-4fa4-8362-f51827a901a0	1	2014-10-03
0121-1488-00	ML - Milliliter	0121-1488	4edf1700-20c9-4897-926a-e4b26d9307ed	1	2018-01-12
0121-1488-10	ML - Milliliter	0121-1488	65e68bfd-3e4b-48bf-a152-400ab8deb4cd	1	2018-01-12
0121-2232-00	ML - Milliliter	0121-2232	bdb3e946-5ff6-4dd9-93b0-d3bb70d80139	1	2018-01-12
0121-2232-15	ML - Milliliter	0121-2232	ae129222-0d56-4e99-9346-76d697c73cd2	1	2018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

GUAIFENESIN
ACESULFAME POTASSIUM
FD&C GREEN NO. 3
FD&C RED NO. 40
HYDROXYETHYL CELLULOSE, UNSPECIFIED
WATER
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0121-0744	0121-0744-04, 0121-0744-08, 0121-0744-16
0121-1744	0121-1744-05, 0121-1744-00
0121-1488	0121-1488-10, 0121-1488-00
0121-2232	0121-2232-15, 0121-2232-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GUAIFENESIN	495W7451VQ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GUAIFENESIN	495W7451VQ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
GUAIFENESIN	495W7451VQ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	8136Y38GY5	SOLUTION / ORAL		1867 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SOLUTION / ORAL		400 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / ORAL	0.25 mg/5ml		Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates

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	GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma	c2e53fb5-2798-47c8-9285-d1077d46e629	2022-06-14	Warnings	Exact identifier ndc (package): 0121-1744-00 ndc (package): 0121-2232-15 ndc (package): 0121-2232-00 ndc (package): 0121-1488-10 ndc (package): 0121-1744-05 ndc (package): 0121-0744-16 ndc (package): 0121-0744-08 ndc (package): 0121-0744-04 ndc (package): 0121-1488-00 ndc (product): 0121-1488 ndc (product): 0121-1744 ndc (product): 0121-2232 ndc (product): 0121-0744 ndc11 (package): 00121148800 ndc11 (package): 00121174400 ndc11 (package): 00121074416 ndc11 (package): 00121074408 ndc11 (package): 00121223200 ndc11 (package): 00121174405 ndc11 (package): 00121223215 ndc11 (package): 00121148810 ndc11 (package): 00121074404 spl id: 25a970c7-0016-4f22-9e94-1e20e1319e3e spl set id: c2e53fb5-2798-47c8-9285-d1077d46e629

Reported adverse events (FAERS/openFDA)#

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