MedPath

Adult Cough and Chest Congestion Relief DM

Drug Facts

Approved
Approval ID

5bd508a0-2f75-413e-a690-bed970131bef

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Safeway, Inc.

DUNS: 009137209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dextromethorphan HBr, Guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-385
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan HBr, Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (11)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 10 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 10 mL
Code: 495W7451VQ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
GLUCOSE OXIDASEInactive
Code: 0T8392U5N1
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

Package Label

![Dextromethorphan HBr 20 mg Guaifenesin 200 mg](/dailymed/image.cfm?name=adult-non-drowsy-cough-and-chest-congestion- relief-1.jpg&id=885436)

SIGNATURE SELECT Tussin Cough & Chest Congestion DM

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/7/2025

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/7/2025

Purposes

Cough suppressant

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 7/7/2025

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.

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/7/2025

Directions

  • do not take more than 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device
  • 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 SECTION

LOINC: 44425-7Updated: 7/7/2025

Other information

  • store between 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2025

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/7/2025

Questions or comments?

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Adult Cough and Chest Congestion Relief DM - FDA Drug Approval Details