FDA.reportPublic FDA data

Maxifed

Manufacturer
MCR American Pharmaceuticals, Inc.
Effective date
2018-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:06

Label at a glance#

ProductMaxifed
Active ingredientGUAIFENESIN, Pseudoephedrine Hydrochloride
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: helps loosen phlegm and thin bronchial secretions to make coughs more productive nasal congestion runny nose sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: ½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (in each immediate-release tablet)Purpose
Guaifenesin 360 mgExpectorant
Pseudoephedrine HCl 60 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • helps loosen phlegm and thin bronchial secretions to make coughs more productive
  • nasal congestion
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage.
  • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

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

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur

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:1 tablet by mouth every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:½ tablet by mouth every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of ageconsult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-352-754-8587

PRINCIPAL DISPLAY PANEL - 360 mg/60 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58605-101-01
100 tablets

Maxifed

Expectorant • Nasal Decongestant

Each immediate-release tablet contains:
Guaifenesin 360 mg
Pseudoephedrine HCl 60 mg

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

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

PRINCIPAL DISPLAY PANEL - 360 mg/60 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 360 mg/60 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2003123guaiFENesin 360 MG / pseudoephedrine HCl 60 MG Oral TabletPSN1
2003123guaifenesin 360 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58605-101-012022-01-28C16284748780-1d6a99b39-3431-a426-e053-dadaa90af4c2Maxifed
58605-101-202022-01-28C16284748780-1d6a99b39-3431-a426-e053-dadaa90af4c2Maxifed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-101-01Maxifed100 in 1 BOTTLE, PLASTICTABLET1001
58605-101-20Maxifed20 in 1 BLISTER PACKTABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-101MAXIFED (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20180401_8a1be614-2a78-4899-9697-774479f2daa5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-101-01EA - Each58605-1013fa393dc-9829-451b-9914-0d4d34ebaa8612018-09-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58605-10158605-101-01, 58605-101-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
Pseudoephedrine Hydrochloride6V9V2RYJ8NACTIB
Magnesium Stearate70097M6I30IACT
Microcrystalline CelluloseOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML · Source PDF

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
f954e296-1429-4985-9d04-a20b67e2cf718a1be614-2a78-4899-9697-774479f2daa52018-03-15WarningsExact identifier
spl id: f954e296-1429-4985-9d04-a20b67e2cf71
spl set id: 8a1be614-2a78-4899-9697-774479f2daa5

Reported adverse events (FAERS/openFDA)#

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