MedPath

MAX Tussin Cough and Chest Congestion DM Sugar Free

Drug Facts

Approved
Approval ID

8f496c61-41a6-41ba-80f5-7a5309c4d18b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

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 Code17856-1126
Application NumberM
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dextromethorphan HBr, Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (12)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 10 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 10 mL
Code: 495W7451VQ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/16/2024

image description

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/16/2024

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: 12/16/2024

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/16/2024

Purposes

Cough suppressant

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 12/16/2024

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

If pregnant or breast-feeding,

ask a health professional before use.

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.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/16/2024

Directions

  • 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 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: 12/16/2024

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/16/2024

Inactive ingredients

anhydrous citric acid, flavor cherry, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sodium citrate, sucralose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/16/2024

Questions or comments?

toll-free 1-877-225-6999

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL33179

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.