FDA.reportPublic FDA data

Maxichlor PEH DM

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 22:55:05

Label at a glance#

ProductMaxichlor PEH DM
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE 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: cough due to minor throat and bronchial irritation associated with a cold alleviates cough to help you sleep non narcotic cough suppressant for relief of cough itchy, watery eyes nasal congestion runny nose sneezing itching of the nose and throat

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 6 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 3 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
Chlorpheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 18 mgCough Suppressant
Phenylephrine HCl 10mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

  • cough due to minor throat and bronchial irritation associated with a cold
  • alleviates cough to help you sleep
  • non narcotic cough suppressant for relief of cough
  • itchy, watery eyes
  • nasal congestion
  • runny nose
  • sneezing
  • itching of the nose and throat

Warnings

WARNINGS SECTION

  • Do not exceed recommended dosage.
  • a persistent cough may be a sign of a serious condition.

Do not use this product

OTC - DO NOT USE SECTION

  • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains 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 where cough is accompanied by excessive phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor 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 marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • 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:1 tablet by mouth every 4 hours, not to exceed 6 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 3 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 (352)754-8587

PRINCIPAL DISPLAY PANEL - 4 mg/18 mg/10 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58605-103-01
100 Tablets

Maxichlor PEH DM

Antihistamine • Cough Suppressant
Nasal Decongestant

Each tablet contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 18 mg
Phenylephrine HCl 10 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 - 4 mg/18 mg/10 mg Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 4 mg/18 mg/10 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2003130chlorpheniramine maleate 4 MG / dextromethorphan HBr 18 MG / phenylephrine HCl 10 MG Oral TabletPSN1
2003130chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 18 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD1
2003130chlorpheniramine maleate 4 MG / dextromethorphan HBr 18 MG / phenylephrine HCl 10 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58605-103-012022-01-28C16284748780-1d6a99b39-ea04-a426-e053-dadaa90af4c2Maxichlor PEH DM
58605-103-202022-01-28C16284748780-1d6a99b39-ea04-a426-e053-dadaa90af4c2Maxichlor PEH DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-103-01Maxichlor PEH DM100 in 1 BOTTLE, PLASTICTABLET1001
58605-103-20Maxichlor PEH DM20 in 1 BLISTER PACKTABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-103MAXICHLOR PEH DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20180401_70bb5a77-8a9b-4794-93e7-90c21482fb8b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-103-01EA - Each58605-1037e118ee7-7277-4a9e-903b-060dc28e7e7312018-09-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58605-10358605-103-01, 58605-103-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
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
9f6e84e3-dba2-4c15-bdcf-bc2c0450f1d970bb5a77-8a9b-4794-93e7-90c21482fb8b2018-03-15WarningsExact identifier
spl id: 9f6e84e3-dba2-4c15-bdcf-bc2c0450f1d9
spl set id: 70bb5a77-8a9b-4794-93e7-90c21482fb8b

Reported adverse events (FAERS/openFDA)#

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