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#
Contacts and useful links#
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-514-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-d471-f424-e053-dadaa90a57ce | Llorens-Triponel 514 |
| 54859-514-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d471-f424-e053-dadaa90a57ce | Llorens-Triponel 514 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-514-16 | Triponel | 474 mL in 1 BOTTLE | LIQUID | 474 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-514-16 | ML - Milliliter | 54859-514 | 8315ea32-8fe0-4b23-bb75-9790aa7acdeb | 1 | 2024-12-10 |
Products#
Every source-derived product name is available through these pages.
- Triponel
- Dextromethorphan HBr, Pseufoephedrine HCl, Triprolidine HCl
- ANHYDROUS CITRIC ACID
- GLYCERIN
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- TRIPROLIDINE HYDROCHLORIDE
- TRIPROLIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-514 | 54859-514-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| TRIPROLIDINE HYDROCHLORIDE | YAN7R5L890 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Triponel | DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL | Llorens Pharmaceutical International Division, Inc. | e9a8deb4-0595-4f0f-ac15-f936f15aca88 | 2025-12-31 | Warnings | 54859-514-16 54859-514 54859051416 474619be-162e-c769-e063-6394a90ac561 e9a8deb4-0595-4f0f-ac15-f936f15aca88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
