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Tusslin Pediatric

Dosage form: solution/ drops
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 7.5mg in 1mL, GUAIFENESIN 88mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Kramer Novis
NDC Code: 52083-623

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients (in each 1 mL)                    Purpose

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

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

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



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

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.


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.


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



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



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.


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

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

TUSSLIN  PEDIATRIC
dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-623
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN88 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
AMMONIUM GLYCYRRHIZATE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:52083-623-0130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2014
Labeler - Kramer Novis (090158395)

Revised: 01/2014
 
Kramer Novis

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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