Maxi-Tuss G

Manufacturer: MCR American Pharmaceuticals, Inc.
Effective date: 2020-06-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:23:30

Label at a glance#

ProductMaxi-Tuss G

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]

Contacts and useful links#

PhoneLabel contact352.754.8587

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 mg	Cough Suppressant
Guaifenesin 100 mg	Expectorant

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)

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.

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 58605-311-16

Maxi-Tuss G
Cough Suppressant ■ Expectorant

Sugar Free ■ Alcohol Free ■ Dye Free

Each teaspoonful (5 mL) for oral administration
contains:
Dextromethorphan HBr 10 mg
Guaifenesin 100 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	1
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	1
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	1
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	1
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58605-311-16	2022-01-28	C162847	48780-1	d6a99b39-821c-a426-e053-dadaa90af4c2	Maxi-Tuss G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58605-311-16	Maxi-Tuss G	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58605-311	MAXI-TUSS G (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20200801_e9dcb3cc-e193-4a63-8544-58eb80cb3581.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58605-311-16	ML - Milliliter	58605-311	914a8f70-1537-4b09-a2ad-5acc7c7efbf0	1	2020-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Maxi-Tuss G
Dextromethorphan Hydrobromide and GUAIFENESIN
Dextromethorphan Hydrobromide
DEXTROMETHORPHAN
GUAIFENESIN
CITRIC ACID MONOHYDRATE
Methylparaben
AMMONIUM GLYCYRRHIZATE
Potassium Citrate
Propylparaben
Propylene Glycol
WATER
Sorbitol
Sucralose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58605-311	58605-311-16

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
Name	UNII	Kind
Dextromethorphan Hydrobromide	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
Methylparaben	A2I8C7HI9T	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
Potassium Citrate	EE90ONI6FF	IACT
Propylparaben	Z8IX2SC1OH	IACT
Propylene Glycol	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
Sucralose	96K6UQ3ZD4	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ec6fb61d-4ce9-40ce-8ced-9980da432cad			e9dcb3cc-e193-4a63-8544-58eb80cb3581	2020-06-24	Warnings	Exact identifier spl id: ec6fb61d-4ce9-40ce-8ced-9980da432cad spl set id: e9dcb3cc-e193-4a63-8544-58eb80cb3581

Reported adverse events (FAERS/openFDA)#

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