CuraHIST DM

Manufacturer
Wittman Pharma, Inc.
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:37

Label at a glance#

ProductCuraHIST DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PYRILAMINE MALEATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Do not exceed the recommended dosage.

Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not

To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor

Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not

to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor

Children under 6 years of age - consult a doctor

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

■ a persistent cough may be a sign of a serious condition.

If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not use this product

■ if you are now taking a prescription monoamine oxidase inhibitor (MADI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains an MADI, ask a doctor or pharmacist before taking this product

■ for persistent or chronic cough such as occurs with

smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm(mucus) unless directed by a doctor

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis ■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

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

If pregnant or breast-feeding, ask a health professional before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms due to 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 associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough

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.

OTC - PURPOSE SECTION

Antitussive/Antihistamine

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each 5 ml teaspoonful)

Dextromethorphan HBr 7.5mg

Pyrilamine Maleate 7.5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CuraHIST DM LabelCuraHIST DM Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1423307dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral SolutionPSN3
1423307dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral SolutionSCD3
1423307dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83335-105-162025-07-29C16284748780-13b156c62-3010-fb37-e063-e6dba90a4e07CuraHIST DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83335-105-16CuraHIST DM473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83335-105CURAHIST DM (DEXTROMETHORPHAN HBR, PYRILAMINE MALEATE) LIQUID [WITTMAN PHARMA, INC.]31 package rows20240405_1019d607-dbd1-5fa0-e063-6394a90aa4d4.zip

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
83335-10583335-105-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
1547dc8e-6664-14b1-e063-6394a90a37db1019d607-dbd1-5fa0-e063-6394a90aa4d42024-04-04WarningsExact identifier
spl id: 1547dc8e-6664-14b1-e063-6394a90a37db
spl set id: 1019d607-dbd1-5fa0-e063-6394a90aa4d4

Reported adverse events (FAERS/openFDA)#

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