Maxi-Tuss PE Max

Manufacturer: MCR American Pharmaceuticals, Inc.
Effective date: 2020-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:23:29

Label at a glance#

ProductMaxi-Tuss PE Max

Active ingredientGUAIFENESIN, Phenylephrine Hydrochloride

Label structure9 sections

Indications and uses

temporarily relieves Nasal congestion due to the common cold Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

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 doctor

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
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

Nasal congestion due to the common cold
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

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

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland
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

nervousness, dizziness, or sleeplessness occur
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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED 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 doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, grape flavor, 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 58605-315-16

Maxi-Tuss PE Max

Expectorant ◾ Nasal Decongestant

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration
contains:
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

Grape 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
1358627	guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution	PSN	1
1358627	guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	1
1358627	guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58605-315-16	2022-01-28	C162847	48780-1	d6a99b39-9009-a426-e053-dadaa90af4c2	Maxi-Tuss PE Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58605-315-16	Maxi-Tuss PE Max	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
58605-315	MAXI-TUSS PE MAX (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20200801_d7505224-87e6-4ce5-a76d-e7637b3f315c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58605-315-16	ML - Milliliter	58605-315	d391e3fb-9e1c-44fe-a3b6-894c50c6595e	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 PE Max
GUAIFENESIN and Phenylephrine Hydrochloride
GUAIFENESIN
Phenylephrine Hydrochloride
PHENYLEPHRINE
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
58605-315	58605-315-16

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
GUAIFENESIN	495W7451VQ	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	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
7118d007-579e-4983-9682-f5bf555605cf			d7505224-87e6-4ce5-a76d-e7637b3f315c	2020-06-25	Warnings	Exact identifier spl id: 7118d007-579e-4983-9682-f5bf555605cf spl set id: d7505224-87e6-4ce5-a76d-e7637b3f315c

Reported adverse events (FAERS/openFDA)#

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