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NDC 54859-0514-16 Triponel 15; 30; 30 mg/5mL; mg/5mL; mg/5mL Details
Triponel 15; 30; 30 mg/5mL; mg/5mL; mg/5mL
Triponel is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 54859-0514 |
|---|---|
| Product ID | 54859-514_ed564072-8e90-470b-9db6-a706403c4b70 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Triponel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Pseufoephedrine HCl, Triprolidine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 15; 30; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
| Labeler Name | Llorens Pharmaceutical International Division, Inc. |
| Pharmaceutical Class | Adrenergic alpha-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-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 54859-0514-16 (54859051416)
| NDC Package Code | 54859-514-16 |
|---|---|
| Billing NDC | 54859051416 |
| Package | 474 mL in 1 BOTTLE (54859-514-16) |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e9a8deb4-0595-4f0f-ac15-f936f15aca88 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 symptoms due to hay fever or upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- 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 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| TRIPONEL
dextromethorphan hbr, pseufoephedrine hcl, triprolidine hcl liquid |
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| Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) |
Revised: 12/2020
Document Id: ed564072-8e90-470b-9db6-a706403c4b70
Set id: e9a8deb4-0595-4f0f-ac15-f936f15aca88
Version: 2
Effective Time: 20201223