FDA.reportPublic FDA data

Maxifed TR Tablets

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 23:23:30

Label at a glance#

ProductMaxifed TR
Active ingredientPseudoephedrine Hydrochloride, Triprolidine Hydrochloride
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 tablets every 4-6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor Children 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 tablet)Purpose
Pseudoephedrine HCl 30 mgNasal Decongestant
Triprolidine HCl 1.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms 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:2 tablets every 4-6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age:Consult 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 - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58605-106-01

Maxifed TR Tablets

Nasal Decongestant • Antihistamine

Each tablet contains:

Pseudoephedrine HCl
30 mg
Triprolidine HCl
1.25 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.

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

100 tablets

Principal Display Panel - 100 Tablet Bottle Label
Principal Display Panel - 100 Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099719pseudoephedrine HCl 30 MG / triprolidine HCl 1.25 MG Oral TabletPSN1
1099719pseudoephedrine hydrochloride 30 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD1
1099719pseudoephedrine HCl 30 MG / triprolidine HCl 1.25 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
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
58605-106-012022-01-28C16284748780-1d6a99b39-dd48-a426-e053-dadaa90af4c2Maxifed TR Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-106-01Maxifed TR100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-106MAXIFED TR (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) TABLET [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200801_daf47021-cf49-4d6f-9dbf-2d0a69da4c9c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-106-01EA - Each58605-106963bc399-94c0-4c91-b961-b1fd75d772b612020-08-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58605-10658605-106-01

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
Pseudoephedrine Hydrochloride6V9V2RYJ8NACTIB
Triprolidine HydrochlorideYAN7R5L890ACTIB
Magnesium Stearate70097M6I30IACT
Microcrystalline CelluloseOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
f75d1e41-3e3a-440a-9768-4bfb71d7668ddaf47021-cf49-4d6f-9dbf-2d0a69da4c9c2020-06-23WarningsExact identifier
spl id: f75d1e41-3e3a-440a-9768-4bfb71d7668d
spl set id: daf47021-cf49-4d6f-9dbf-2d0a69da4c9c

Reported adverse events (FAERS/openFDA)#

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