Label at a glance#

ProductGUAIFENESIN DM

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN

Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Storage and handling

STORAGE: 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

Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant

DESCRIPTION

OTC - ACTIVE INGREDIENT SECTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin	100 mg
Dextromethorphan Hydrobromide	10 mg

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

Sodium Content: 4 mg/5 mL

USES

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

WARNINGS

WARNINGS SECTION

OTC - DO NOT USE SECTION

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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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.

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: 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 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years	2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 years	ask a doctor

HOW SUPPLIED SECTION

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:

NDC 63739-505-01 5 mL unit dose cup

NDC 63739-505-10 Case contains 100 unit dose cups of 5 mL (63739-505-01) packaged in 10 trays of 10 unit dose cups each.

NDC 63739-506-01 10 mL unit dose cup

NDC 63739-506-10 Case contains 100 unit dose cups of 10 mL (63739-506-01) packaged in 10 trays of 10 unit dose cups each.

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 63739-505-01

GUAIFENESIN SYRUP
and DEXTROMETHORPHAN

100 mg/10 mg per 5 mL

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

Memphis, TN 38141

SEE INSERT

F0638C050923

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 63739-506-01

GUAIFENESIN SYRUP

and DEXTROMETHORPHAN

200 mg/20 mg per 10 mL

Package Not Child-Resistant

DISTRIBUTIONED BY

SKY Packaging

Memphis, TN 38141

See insert

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-505	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [MCKESSON CORPORATION DBA SKY PACKAGING]	3	Unmatched	20250308_0826ed78-ce8a-4fea-81dc-57a2636a3197.zip
63739-506	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [MCKESSON CORPORATION DBA SKY PACKAGING]	3	Unmatched	20250308_0826ed78-ce8a-4fea-81dc-57a2636a3197.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-505-01	ML - Milliliter	63739-505	75510fcd-474a-49bc-99b6-a051910cdae7	1	2024-02-14
63739-505-10	ML - Milliliter	63739-505	7783e8aa-4c94-488e-9dca-1d028f52e4b3	1	2024-02-14
63739-506-01	ML - Milliliter	63739-506	470b0f26-092e-4add-b53c-6070e565ff5e	1	2024-02-14
63739-506-10	ML - Milliliter	63739-506	aef1207a-4a1b-4d5f-98ba-7f255fc7982f	1	2024-02-14

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

GUAIFENESIN DM
GUAIFENESIN and DEXTROMETHORPHAN
GUAIFENESIN
DEXTROMETHORPHAN
DEXTROMETHORPHAN HYDROBROMIDE
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
MENTHOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63739-505	63739-505-01, 63739-505-10
63739-506	63739-506-01, 63739-506-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN	7355X3ROTS	ACTIR
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SUCROSE	C151H8M554	IACT
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN	7355X3ROTS	ACTIR
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SUCROSE	C151H8M554	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
WATER	059QF0KO0R	IACT

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
f7ceb746-1c86-4b4c-bc42-7c7ca0cb7c02			0826ed78-ce8a-4fea-81dc-57a2636a3197	2024-01-11	Warnings	Exact identifier spl id: f7ceb746-1c86-4b4c-bc42-7c7ca0cb7c02 spl set id: 0826ed78-ce8a-4fea-81dc-57a2636a3197

Reported adverse events (FAERS/openFDA)#

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