FDA.reportPublic FDA data

Mucolyte

Manufacturer
Rising Pharma Holdings, Inc. | Invahealth Inc.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:00

Label at a glance#

ProductMucolyte DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each 5 mL teaspoonful)

Guaifenesin, USP 100 mg

Dextromethorphan Hydrobromide, USP 10 mg

OTC - PURPOSE SECTION

Purposes

Expectorant

Cough Suppressant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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.

Do not use if you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • 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 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.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
 adults and children 12 years and over 2 teaspoonfuls (10 mL)
 children under 12 years do not use

Other Information

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
  • do not refrigerate
  • TAMPER-EVIDENT: Do not use if foil seal over bottle is torn, broken or missing
  • Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose, water.

Questions or comments

OTC - QUESTIONS SECTION

Call 1-844-474-7464

OTHER SAFETY INFORMATION

*This product is neither manufactured nor distributed by the owner of the registered trademark Robitussin®-DM

MUCOLYTE-DMTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mucolyte-DMmucolyte-DM

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357237360163GTIN-13: 0357237360163
EAN-13: 0357237360163
GTIN-12: 357237360163
UPC-A: 357237360163
GTIN storage (14 digits): 00357237360163		mucolyte-DM.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-360-12MucolyteDM118 mL in 1 BOTTLELIQUID1181
57237-360-16MucolyteDM473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-360-12ML - Milliliter57237-360cd7cc154-3aa2-458a-862c-d765eca1df7312026-01-08
57237-360-16ML - Milliliter57237-3601bc9e866-3de7-4f28-b05c-54e2aac5c20012026-01-08

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-36057237-360-12, 57237-360-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM SACCHARINSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
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
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
ndc (package): 57237-360-16
ndc (package): 57237-360-12
ndc (product): 57237-360
ndc11 (package): 57237036012
ndc11 (package): 57237036016
spl id: e0d8faa2-7ca9-49c9-bae0-138fea576c68
spl set id: c913d27d-bc00-4ace-9a5f-c55522e1cd1d

Reported adverse events (FAERS/openFDA)#

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