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NDC 54859-0508-16 Triponel 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL Details
Triponel 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL
Triponel is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
NDC | 54859-0508 |
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Product ID | 54859-508_bce65e4f-a4b1-4b28-b6f9-ac1f614dec82 |
Associated GPIs | |
GCN Sequence Number | 085428 |
GCN Sequence Number Description | triprolidine/phenylephrine/DM LIQUID 1.25-5MG/5 ORAL |
HIC3 | B3R |
HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
GCN | 54906 |
HICL Sequence Number | 041030 |
HICL Sequence Number Description | TRIPROLIDINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR |
Brand/Generic | Brand |
Proprietary Name | Triponel |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 15; 5; 1.25 |
Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
Labeler Name | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 54859-0508-16 (54859050816)
NDC Package Code | 54859-508-16 |
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Billing NDC | 54859050816 |
Package | 474 mL in 1 BOTTLE (54859-508-16) |
Marketing Start Date | 2019-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cc774d33-96ce-4992-ad30-3cb03b0d119d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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 symptomes due to hay fever or ther upper respiratory allergies
- runny nose
- itchy, watery eyes
- sneexing
- itching of the nose or throat
SPL UNCLASSIFIED SECTION
Warnings
Do not use if you are taking a 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 you r prescirption drug contains an MAOI, ask a doctor or pharmacist before using this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of 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, tranquilizers 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, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness dizziness, or sleeplessness occurs
- cough lasts for more than 7 days, comes back, or occurs with a beer, rash, or headache that lasts. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
TRIPONEL
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid |
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Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305) |