FDA.reportPublic FDA data

Adult Tussin Cough and Chest Congestion DM Sugar Free

Manufacturer
ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date
2022-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:37

Label at a glance#

ProductAdult Tussin Cough and Chest Congestion DM Sugar Free
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

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

Dosage and administration

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 adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use

Storage and handling

Phenylketonurics: contains Phenylalanine 30 mg per 10 mL store between 20-25ºC(68-77ºF). Do not refrigerate

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

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 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.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
  • store between 20-25ºC(68-77ºF). Do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

Questions or comments?

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5ML5ML

10ML10ML

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1006-12024-01-30C16284748780-11030e365-5c9a-111a-e063-dadaa90a10e2Drug Facts
17856-1006-22024-01-30C16284748780-11030e365-5c9a-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1006-1Adult Tussin Cough and Chest Congestion DM Sugar Free72 in 1 BOX, UNIT-DOSELIQUID721
17856-1006-2Adult Tussin Cough and Chest Congestion DM Sugar Free72 in 1 BOX, UNIT-DOSELIQUID721
17856-1006-3Adult Tussin Cough and Chest Congestion DM Sugar Free5 mL in 1 CUP, UNIT-DOSELIQUID51
17856-1006-4Adult Tussin Cough and Chest Congestion DM Sugar Free10 mL in 1 CUP, UNIT-DOSELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1006ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 4 package rows20221118_51b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1006-1ML - Milliliter17856-1006b78a3df0-4e5b-4cef-a192-774b4cc5a5e112023-04-07
71399-1006-4ML - Milliliter71399-1006764c12f7-04c5-4b6b-b050-df18ac5bcc5c12022-12-07
71399-1006-6ML - Milliliter71399-1006e4281b10-ba01-4d87-81ba-cfeace3f259312022-12-07
71399-1006-8ML - Milliliter71399-1006d974150e-75d0-4241-bc5d-9be27b0d32e712022-12-07

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
17856-100617856-1006-3, 17856-1006-1, 17856-1006-4, 17856-1006-2
71399-1006

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
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
773d490b-05ea-4986-8065-911bea8f046951b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b2022-11-11WarningsExact identifier
spl id: 773d490b-05ea-4986-8065-911bea8f0469
spl set id: 51b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b

Reported adverse events (FAERS/openFDA)#

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