Triponel

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:46

Label at a glance#

ProductTriponel
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Dextromethorphan HBr

Pseudoephedrine HCl

Triprolidine HCl

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

INDICATIONS & USAGE SECTION

Uses

  • helps to control the reflex that causes coughing
  • temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic: rhinitis)
  • temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

WARNINGS SECTION

Warnings

Do not use if you are taking a monoamine oxidase inhibitor (MAOI) (certain drugs for drepssion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presciption drug conatins an MAOI, ask a doctor or pharmacist before using this product.

Ask a doctor before use if you have 

  • heart disaese
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to an enlargment of the prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if you are taking sedatives, transquilizers or drugs for depression or MAOI drugs. 

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedative and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machiney

Stop use and ask a doctor if

  • nervoisness, dizziness or sleeplessness occurs
  • cough lasts for more than 7 days, comes back, or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact Poinson Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

 Age Dose
 Adults and children 12 years of age and over

 Take 2 teaspoonfuls (10 mL) every 6 hours

 Children 6 to under 12 years of age Take 1 teaspoonful (5mL) every 6 hours
 Children under 6 Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

OTC - QUESTIONS SECTION

Questions or Comments? 1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TriponelTriponel

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
54859-514-162020-12-23C16284748780-19d75b9d0-d471-f424-e053-dadaa90a57ceLlorens-Triponel 514
54859-514-162020-01-31C16284748780-19d75b9d0-d471-f424-e053-dadaa90a57ceLlorens-Triponel 514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-514-16Triponel474 mL in 1 BOTTLELIQUID4745

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-514-16ML - Milliliter54859-5148315ea32-8fe0-4b23-bb75-9790aa7acdeb12024-12-10

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
54859-51454859-514-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
ndc (package): 54859-514-16
ndc (product): 54859-514
ndc11 (package): 54859051416
spl id: 474619be-162e-c769-e063-6394a90ac561
spl set id: e9a8deb4-0595-4f0f-ac15-f936f15aca88

Reported adverse events (FAERS/openFDA)#

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