FDA.reportPublic FDA data

AXIV DM Max

Manufacturer
VIVUNT PHARMA LLC | Rnv LLC
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:31

Label at a glance#

ProductAXIV DM Max
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

Dosage and administration

do not take more than 6 doses in any 24-hour period this adult strength product is not intended for use in children under 12 years of age measure only with dosing cup provided keep dosing cup with product mL = milliliter age dose adults and children 12 years of age and older 20 mL every 4 hours children under 12 years of age do not use

Storage and handling

each 20 mL contains: sodium 7 mg store at 15-30°C (59-86°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - WHEN USING SECTION

Do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

  • do not take more than 6 doses in any 24-hour period
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
agedose
adults and children 12 years of age and older20 mL every 4 hours
children under 12 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 7 mg
  • store at 15-30°C (59-86°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Blue #1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

SPL UNCLASSIFIED SECTION

PEEL CORNER TO READ COMPLETE DRUG FACTS AND INFORMATION/ DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178

Made in USA

www.vivunt.live

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maximum Strength Mucinex® Fast-Max®

NDC 82706-024-01

AXIV - DM MAX

Cough Relief

Cough Suppressant
Expectorant

Maximum Strength

Non-Drowsy

Dextromethorphan HBr

Guaifenesin

6 FL OZ (177 mL)

axdmaxdm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
82706-024-01AXIV DM Max177 mL in 1 BOTTLE, PLASTICLIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-024AXIV DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [VIVUNT PHARMA LLC]1Current NDC, 1 package rows20240516_18704e66-ee8f-315d-e063-6294a90a5282.zip

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
82706-02482706-024-01

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
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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
AXIV DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC18704e66-ee8f-315d-e063-6294a90a52822024-05-14WarningsExact identifier
ndc (package): 82706-024-01
ndc (product): 82706-024
ndc11 (package): 82706002401
spl id: 18704e66-ee92-315d-e063-6294a90a5282
spl set id: 18704e66-ee8f-315d-e063-6294a90a5282

Reported adverse events (FAERS/openFDA)#

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