FDA.reportPublic FDA data

QCH Adult Tussin DM Sugar free 545

Manufacturer
Chain Drug Marketing Association Inc. | Guardian Drug Company
Effective date
2024-05-08
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:10

Label at a glance#

ProductQCH Adult Tussin DM Sugar free 545
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure13 sections

Dosage and administration

shake well before using  do not take more than 6 doses in any 24-hour period  measure only with dosing cup provided  keep dosing cup with product  ml=milliliter  this adult product is not intended for use in children under 12 years of age Age  Dose   adults & children  12 years & over  20 mL every 4 Hours  Children under 12 years  do not use

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg 

Guaifenesin, USP 200 mg

PURPOSE

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

USE(S)

INDICATIONS & USAGE SECTION

  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with a cold 
  • helps loosen phlegm (mucus)and thin bronchial secretions to drain bronchial tubes

WARNINGS

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

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 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.




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

  • shake well before using 
  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided 
  • keep dosing cup with product 
  • ml=milliliter 
  • this adult product is not intended for use in children under 12 years of age

Age Dose 
 adults & children  12 years & over 20 mL every 4 Hours
 Children under 12 years do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each 20 mL contains: sodium 15 mg
  • store at 20-25oC (68-77oF)
  • do not refrigerate

INACTIVE INGRADIENTS

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water , sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83324-025-04

QUALITY CHOICE

* Compare to the Active Ingredients in Robitussin® DM

Adult Tussin DM

Cough Suppressant/ Expectorant

Dextromethorphan HBr 20 mg per 20 mL 

Guaifenesin 200 mg per 20 mL

For Ages 12 & Over 

Helps Control Cough 

Relieves Chest Congestion 

Thins  and Loosens Mucus

Specially Formulated for Diabetics

Non-Drowsy

Sugar Free Dye Free

Peppermint Flavor

4 FL OZ (118 mL)

545-qch-label.jpg545-qch-label.jpg

545-qch-carton.jpg545-qch-carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN2
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD2
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY2
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY2
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-025-04QCH Adult Tussin DM Sugar free 5451 in 1 CARTONLIQUID12
83324-025-04QCH Adult Tussin DM Sugar free 545118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-025QCH ADULT TUSSIN DM SUGAR FREE 545 (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 2 package rows20240509_17cb91f0-32ec-9e0f-e063-6394a90a0509.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-025-04ML - Milliliter83324-025ee16476e-2bb4-4da0-95c5-1c5e03665b7112026-05-22

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-02583324-025-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
QCH Adult Tussin DM Sugar free 545DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17cb91f0-32ec-9e0f-e063-6394a90a05092024-05-08WarningsExact identifier
ndc (package): 83324-025-04
ndc (product): 83324-025
ndc11 (package): 83324002504
spl id: 86cc0533-cf2e-4227-8123-179cb12272a2
spl set id: 17cb91f0-32ec-9e0f-e063-6394a90a0509

Reported adverse events (FAERS/openFDA)#

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