FDA.reportPublic FDA data

M-END

Manufacturer
R. A. McNeil Company
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:40:44

Label at a glance#

ProductM-END DMX
Active ingredientDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE 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 cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed 4 doses in a 24 hour period. Adults and children 12 years of age and over: 3 teaspoonfuls (15 mL) every 6 hours, not to exceed 12 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1 1/2 teaspoonfuls (7.5 mL) every 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a Physician.

Storage and handling

Store at 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 5 mL teaspoonful)
Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Antitussive

Cough Suppressant

Nasal Decongestant

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
  • cough due to minor throat and bronchial irritation
  • 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
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

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 marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizes may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occur
  • new symptoms occur

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed 4 doses in a 24 hour period.

Adults and children
12 years of age
and over:

3 teaspoonfuls (15 mL)
every 6 hours, not to
exceed 12 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:



1 1/2 teaspoonfuls
(7.5 mL) every 6 hours,
not to exceed 6
teaspoonfuls in
24 hours
Children under 6
years of age:
Consult a Physician.

Other information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-423-493-9170

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M-END DMX Labeling 1.jpgM-END DMX Labeling 1.jpg

M-END DMX Labeling 2.jpgM-END DMX Labeling 2.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1190600dexbrompheniramine maleate 0.667 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 20 MG in 5 mL Oral SolutionPSN9
1190600dexbrompheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 4 MG/ML Oral SolutionSCD9
1190600dexbrompheniramine maleate 0.667 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 20 MG per 5 ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
12830-816-162024-03-19C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162024-03-19C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302024-03-19C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302024-03-19C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162024-01-30C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162024-01-30C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302024-01-30C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302024-01-30C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162022-12-22C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162022-12-22C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302022-12-22C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302022-12-22C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162022-07-29C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-162022-07-29C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302022-07-29C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX
12830-816-302022-07-29C16284748780-1e4f33bdf-b31c-d8a0-e053-dadaa90a6e4eM-END DMX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12830-816-16M-ENDDMX473 mL in 1 BOTTLELIQUID4739
12830-816-30M-ENDDMX30 mL in 1 BOTTLELIQUID309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12830-816-16ML - Milliliter12830-8167caf2d65-b241-4862-9fda-e1c89f90c2c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dexbrompheniramine MaleateACTIVE INGREDIENTBPA9UT29BS2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8N2
DexbrompheniramineACTIVE MOIETY75T64B71RP2
DextromethorphanACTIVE MOIETY7355X3ROTS2
PseudoephedrineACTIVE MOIETY7CUC9DDI9F2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V32
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR2
SorbitolINACTIVE INGREDIENT506T60A25R2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD42
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12830-81612830-816-16, 12830-816-30

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
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-03-15full-release2026-06-01 00:10:05

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 69 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
54 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii+route
54 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
54 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
54 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SUSPENSION / ORAL383 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
54 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii+route
54 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
54 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
54 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
54 equally ranked IID candidates

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
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
ndc (package): 12830-816-30
ndc (package): 12830-816-16
ndc (product): 12830-816
ndc11 (package): 12830081630
ndc11 (package): 12830081616
spl id: 413d30e9-616e-f896-e063-6394a90acebc
spl set id: ee1fae2e-3a21-4487-9989-c7620a4a7056

Reported adverse events (FAERS/openFDA)#

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