Tusnel Pediatric Drops

Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:43

Label at a glance#

ProductTusnel Pediatric Drops
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients in each (1 mL)

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

WARNINGS SECTION

Warnings

Do not use in child whos 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 an MAOI: ask your doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that occurs with too much phlegm
  • a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product

  • do not exceed the recommended dosage.

Stop use and ask doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

 Age Weight Dose
 Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours
 Children under 2 years of age Under 24 lbs Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

OTC - QUESTIONS SECTION

Questions or Comments? 1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tusnelpedtusnelped

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2268063guaiFENesin 25 MG / phenylephrine HCl 1.25 MG in 1 mL Oral SolutionPSN4
2268063guaifenesin 25 MG/ML / phenylephrine hydrochloride 1.25 MG/ML Oral SolutionSCD4
2268063guaifenesin 25 MG / phenylephrine hydrochloride 1.25 MG per 1 mL Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-605-01Tusnel Pediatric Drops30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS304

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-60554859-605-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
ndc (package): 54859-605-01
ndc (product): 54859-605
ndc11 (package): 54859060501
spl id: 47462c1c-38e8-e1af-e063-6394a90a4955
spl set id: dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.