FDA.reportPublic FDA data

Expectorant DM Tasty Cough Syrup

Manufacturer
Weeks & Leo Co., Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:12

Label at a glance#

ProductCarolina Crud Crusher
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to: drain bronchial tubes make coughs more productive rid bronchial passageways of bothersome mucus temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Dosage and administration

take every 4 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 2 teaspoonfuls (10 mL) children 6 to under 12 years 1 teaspoonful (5 mL) children 2 to under 6 years 1/2 teaspoonful (2-1/2 mL) children under 2 years ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

in each teaspoonful (5 mL)

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to:
  • drain bronchial tubes
  • make coughs more productive
  • rid bronchial passageways of bothersome mucus
  • temporarily relieve cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

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.

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts for more than 1 week, comes back, or occurs with a fever, rash, or headache that lasts. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over2 teaspoonfuls (10 mL)
children 6 to under 12 years1 teaspoonful (5 mL)
children 2 to under 6 years 1/2 teaspoonful (2-1/2 mL)
children under 2 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20º C to 25º C (68º F 77º F)
  • do not refrigerate
  • to report serious side effects due to the use of this product call (515) 276-1586

INACTIVE INGREDIENT SECTION

citric acid (anhydrous), FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

64-311-08v1.1 Label64-311-08v1.1 LabelCarolina Crud Crusher

Expectorant DM Tasty Cough Syrup

  • Loosens & Relieves Chest Congestion
  • Cough Suppressant

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY2

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
11383-311-08Carolina Crud Crusher236 mL in 1 BOTTLESYRUP2362

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11383-31111383-311-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
Carolina Crud CrusherDEXTROMETHORPHAN HBR, GUAIFENESINWeeks & Leo Co., Inc.0b606683-7d68-cca5-e063-6394a90a6f582025-12-03WarningsExact identifier
ndc (package): 11383-311-08
ndc (product): 11383-311
ndc11 (package): 11383031108
spl id: 4510c108-2685-f505-e063-6394a90ab0a4
spl set id: 0b606683-7d68-cca5-e063-6394a90a6f58

Reported adverse events (FAERS/openFDA)#

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