FDA.reportPublic FDA data

GUAIFENESIN and DEXTROMETHORPHAN SYRUP Drug Facts

Manufacturer
American Health Packaging
Effective date
2024-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:42

Label at a glance#

ProductGuaifenesin DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN
Label structure11 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

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 (yr) Dose (mL) 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

Label contents#

Full prescribing information#

Active ingredient (in each 10 mL Cup)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg
Dextromethorphan Hydrobromide 20 mg

Purpose

OTC - PURPOSE SECTION

Expectorant
Cough Suppressant

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

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 (yr)

Dose (mL)

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

Other Information

OTHER SAFETY INFORMATION

  • Each 10 mL contains: sodium 8 mg
  • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms:
    5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17
    10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

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).

Distributed by:
American Health Packaging
Columbus, OH 43217

R0324

Package/Label Principal Display Panel - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GUAIFENESIN and DEXTROMETHORPHAN SYRUP LabelGUAIFENESIN and DEXTROMETHORPHAN SYRUP Label

Case NDC 60687-828-56/Cup NDC 60687-828-42

GUAIFENESIN and
DEXTROMETHORPHAN
SYRUP

Expectorant/Cough Suppressant

200 mg/20 mg per 10 mL

Non-Narcotic, Alcohol Free
Cherry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0638C100324                 R03/24

Package/Label Principal Display Panel – Cup Lid – 200 mg/20 mg per 10 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GUAIFENESIN and DEXTROMETHORPHAN SYRUP Cup Lid
GUAIFENESIN and DEXTROMETHORPHAN SYRUP Cup Lid

NDC 60687- 828-42

Guaifenesin and
Dextromethorphan Syrup

Expectorant/cough Suppressant

200 mg/20 mg per 10 mL

Sodium Content: 8 mg/10 mL

Delivers 10 mL

Protect from light

See package Drug Facts insert for full
prescribing information and storage

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0638C100224

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

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
60687-828-42Guaifenesin DM10 mL in 1 CUP, UNIT-DOSESYRUP101
60687-828-48Guaifenesin DM10 in 1 TRAYSYRUP101
60687-828-56Guaifenesin DM10 in 1 CASESYRUP101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-828GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240807_8632a655-7f5b-450f-95fa-62478a174e9c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-828-42ML - Milliliter60687-8286d4e5ec6-2f1e-454e-b08f-9e0c798fe8e012024-08-12
60687-828-56ML - Milliliter60687-828d2313ab3-6e3c-49be-b3e5-8e3d61f4dcdc12024-08-12

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60687-82860687-828-42, 60687-828-48, 60687-828-56

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCROSEC151H8M554IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN7355X3ROTSACTIR

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 DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
ndc (package): 60687-828-48
ndc (package): 60687-828-56
ndc (package): 60687-828-42
ndc (product): 60687-828
ndc11 (package): 60687082856
ndc11 (package): 60687082848
ndc11 (package): 60687082842
spl id: 1d74f48d-1aa4-b779-e063-6394a90af176
spl set id: 8632a655-7f5b-450f-95fa-62478a174e9c

Reported adverse events (FAERS/openFDA)#

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