Triponel Liquid
FDA Label NDC 54859-508

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 Pharmaceuticals International Division for the product Triponel (NDC 54859-508). 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 (in each 5 mL)

Dextromethorphan HBr 15 mg

Phenylephrine HCl 5 mg

Triprolidine HCl 1.25 mg

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 symptomes due to hay fever or ther upper respiratory allergies
  • runny nose
  • itchy, watery eyes
  • sneexing
  • itching of the nose or throat

Warnings

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Direcations: 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 (5 mL) every 6 hours
 Children under 6 Ask a docotor

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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