Endal

Manufacturer
Poly Pharmaceuticals, Inc.
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:38

Label at a glance#

ProductEndal
Active ingredientTRIPROLIDINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

AGE DOSE Adults and children over 12 years of age 2 teaspoonfuls (10 mL) every 4 to 6 hours, over 12 years not to exceed 8 teaspoonfuls in of age: 24 hours, or as directed by a doctor. Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours, 12 years of age: not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor.

Storage and handling

Store at 59° - 86°F (15° - 30°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Triprolidine HCl, Dextromethorphan HBr

Purpose

OTC - PURPOSE SECTION

Antihistimine, Antitussive

Uses

INDICATIONS & USAGE SECTION

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

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
  • difficulty in urination due to the enlargement of the 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
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

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
  • may cause or aggravate constipation
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect

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

  • new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the 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

AGEDOSE
Adults and children over 12 years of age2 teaspoonfuls (10 mL) every 4 to 6 hours,
over 12 years not to exceed 8 teaspoonfuls in
of age: 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 to 6 hours,
12 years of age: not to exceed 4 teaspoonfuls in
24 hours, or as directed by a doctor.
Children under 6 years of ageConsult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution.

Questions? Comments?

OTC - QUESTIONS SECTION

Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon - Fri (8 a.m. to 5 p.m. CST)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637485dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG in 5 mL Oral SolutionPSN4
2637485dextromethorphan hydrobromide 2 MG/ML / triprolidine hydrochloride 0.25 MG/ML Oral SolutionSCD4
2637485dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350991136166GTIN-13: 0350991136166
EAN-13: 0350991136166
GTIN-12: 350991136166
UPC-A: 350991136166
GTIN storage (14 digits): 00350991136166
endal.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-136-05Endal5 mL in 1 BOTTLELIQUID54
50991-136-15Endal15 mL in 1 BOTTLELIQUID154
50991-136-16Endal473 mL in 1 BOTTLELIQUID4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-136-16ML - Milliliter50991-1366c3b1d25-9b9b-45fc-811c-23e2f0c7e36612023-07-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-13650991-136-16, 50991-136-15, 50991-136-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-07-09full-release2026-06-01 00:15:05

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
EndalTRIPROLIDINE HCL, DEXTROMETHORPHAN HBRPoly Pharmaceuticals, Inc.fc5401e2-ed65-72e7-e053-6294a90a81f32025-10-30WarningsExact identifier
ndc (package): 50991-136-15
ndc (package): 50991-136-16
ndc (package): 50991-136-05
ndc (product): 50991-136
ndc11 (package): 50991013605
ndc11 (package): 50991013616
ndc11 (package): 50991013615
spl id: 42678322-4335-74c0-e063-6394a90a77cb
spl set id: fc5401e2-ed65-72e7-e053-6294a90a81f3

Reported adverse events (FAERS/openFDA)#

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