Tusslin
FDA Label NDC 52083-623

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Tusslin (NDC 52083-623). 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, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, 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 1 mL)                    Purpose

Dextromethorphan HBr, 7.5 mg..............................Antitussive

Guaifenesin, 88 mg..............................................Expectorant

Phenylephrine HCl, 2.5 mg................................Nasal decongestant



Otc - Purpose

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • nasal congestion due to the common cold
    • cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings


Warnings

Do not use
in child who is taking a prescription 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 your child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product.

Otc - Do Not Use


Ask a doctor before use if your child has
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • a cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with asthma

    • When using this product do not exceed recommended dosage

    Stop use and ask a doctor if
    • new symptoms occur
    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a 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 accidental overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration


Directions

do not use more than 4 doses in any 24-hour period

Children 6 to under 12 years of age

  • 2 mL every 6 hours, do not exceed 4 doses.

    • Children 2 to under 6 years of age

    • 1 mL every 6 hours, do not exceed 4 doses, or as directed by a doctor.

      • Children under 2, consult a doctor

      • measure with the dosage device provided. Do not use any other device.

Indications & Usage


Other information

Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

Store at controlled room temperature 15-30°C (59-86°F).

Avoid excessive heat and humidity.

Inactive Ingredient


Inactive ingredients Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Otc - Questions

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.
Tel: (787) 767-2072
www.kramernovis.com

Principal Display Panel

TUSSLIN®

PEDIATRIC DROPS

Contains the same active ingredients as Glituss® Pediatric

Antitussive

Expectorant

Nasal Decongestant

Sugar, Alcohol & Dye Free

NET CONTENT: 30 mL (1 Fl. Oz.)

KRAMER-NOVIS

Kramer-supress-pe (Tusslin)

Kramer-supress-pe (Tusslin)

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