Triponel Liquid
FDA Label NDC 54859-514

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Triponel (NDC 54859-514). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Dextromethorphan HBr

Pseudoephedrine HCl

Triprolidine HCl

Otc - Purpose

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

Indications & Usage

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

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

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

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

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

Otc - Questions

Questions or Comments? 1-866-595-5598

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Triponel (Triponel)

Triponel (Triponel)

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