FDA.reportPublic FDA data

Maxi-Tuss GMX

Manufacturer
MCR American Pharmaceuticals, Inc.
Effective date
2020-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:21

Label at a glance#

ProductMaxi-Tuss GMX
Active ingredientDextromethorphan Hydrobromide, GUAIFENESIN
Label structure9 sections

Indications and uses

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 exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor Children under 6 years of age: Consult a physician

Storage and handling

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients
(in each 5 mL teaspoonful)		Purpose
Dextromethorphan HBr 10 mgCough Suppressant
Guaifenesin 200 mgExpectorant

Uses

INDICATIONS & USAGE SECTION

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 exceed recommended dosage.

Do not use this product

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 - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
Children under 6 years of age:Consult a physician

Other information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call 352.754.8587

Principal Display Panel - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58605-312-16

Maxi-Tuss GMX
Cough Suppressant ■ Expectorant

Sugar Free ■ Alcohol Free ■ Dye Free

Each teaspoonful (5 mL) for oral administration
contains:
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

Cherry Flavor

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
MCR American Pharmaceuticals, Inc.
Brooksville, FL 34604

16 fl oz (473 mL)

Principal Display Panel - 473 mL Bottle Label
Principal Display Panel - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046631dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 10 mL Oral SolutionPSN1
1046631dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD1
1046631dextromethorphan HBr 10 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY1
1046631dextromethorphan HBr 20 MG / guaifenesin 400 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
58605-312-162022-01-28C16284748780-1d6a99b39-aab7-a426-e053-dadaa90af4c2Maxi-Tuss GMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-312-16Maxi-Tuss GMX473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-312MAXI-TUSS GMX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200801_5556850c-c6b4-48f8-b8ba-3192836c5b15.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-312-16ML - Milliliter58605-312f626f75f-50cd-4c33-8dce-b2f7f143447e12020-08-06

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
58605-31258605-312-16

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MethylparabenA2I8C7HI9TIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
Potassium CitrateEE90ONI6FFIACT
PropylparabenZ8IX2SC1OHIACT
Propylene Glycol6DC9Q167V3IACT
WATER059QF0KO0RIACT
Sorbitol506T60A25RIACT
Sucralose96K6UQ3ZD4IACT

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
4d67eeb7-1a8c-4d86-8d20-bcdb99d393265556850c-c6b4-48f8-b8ba-3192836c5b152020-06-23WarningsExact identifier
spl id: 4d67eeb7-1a8c-4d86-8d20-bcdb99d39326
spl set id: 5556850c-c6b4-48f8-b8ba-3192836c5b15

Reported adverse events (FAERS/openFDA)#

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