Tesalon Children

Manufacturer
OPMX LLC | GADAL Laboratories, Inc
Effective date
2024-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:12

Label at a glance#

ProductTesalon Children
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

Uses temporarily relieves these common cold and flu symptoms: sinus congestion and pressure minor aches and pains nasal congestion cough due to minor throat and bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL=milliliter tsp=teaspoonful Children 6 to under 12 years of age 10mL or 2 tsp in dosing cup provided every 4 hours Children under 6 years of age do not use

Storage and handling

each 10 mL contains: sodium 10mg store between 20-25°C (68-77°F) do not refrigerate keep carton for complete Drug Facts

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients ________________Purposes

(in each 10mL= 2 teaspoonfull)

Acetaminophen 250mg ........................Pain reliever/fever reducer

Dextromethorphan HBr 13.33mg..........Cough suppressant

Guaifesin USP 200mg...........................Expectorant

Phenylephrine HCl 5mg.........................Nasal descongestant

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL=2 teaspoonful)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan HBr 13.33mgCough suppressant
Guaifenesin USP 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

temporarily relieves these common cold and flu symptoms:

  • sinus congestion and pressure
  • minor aches and pains
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sodium restricted diet

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL=milliliter
  • tsp=teaspoonful

Children 6 to under 12 years of age 10mL or 2 tsp in dosing cup provided every 4 hours
Children under 6 years of age do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains:
  • sodium 10mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • keep carton for complete Drug Facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera, citric acid, disodium EDTA, FD&C red no 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol USP, purified water, sodium benzoate, sorbitol 70% USP, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 619-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-786-06

Tesalon®

Infantil

Gripe, Resfriado & Garganta Irritada

Máxima Potencia

  • Alivia Fiebre y Dolor de Cabeza

(Acetaminophen)

  • Control de la Tos

(Dextromethorphan HBr)

  • Adelgaza y Expulsa las Flemas

(Guaifenesin)

  • Alivia la Congestión Nasal

(Phenylephrine HCl)

Alivio hasta por 8 horas

Caja con frasco de 6FL OZ (177mL)

y vasito dosificador

NDC 69729-786-06

Tesalon®

Children

Cold, Flu & Sore Throat

Maximum Strenght

  • Relieves Headache & Fever

(Acetaminophen)

  • Controls Cough

(Dextromethorphan HBr)

  • Thins & Loosens Mucus

(Guaifenesin)

  • Relieves Nasal Congestion

(Phenylephrine HCl)

Relief up to 8 hours

Box with bottle of 6 FL OZ (177mL)

and measuring cup Tesalon Children 6 fl ozTesalon Children 6 fl oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SolutionPSN1
1790651acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY1
1790651acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1790651APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-786-06Tesalon Children1 in 1 CARTONSYRUP11
69729-786-06Tesalon Children177 mL in 1 BOTTLE, PLASTICSYRUP1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-786TESALON CHILDREN (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL) SYRUP [OPMX LLC]1Current NDC, 2 package rows20240929_2309620a-ccbc-41e9-e063-6394a90a9520.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-78669729-786-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
ndc (package): 69729-786-06
ndc (product): 69729-786
ndc11 (package): 69729078606
spl id: 2309620a-ccbd-41e9-e063-6394a90a9520
spl set id: 2309620a-ccbc-41e9-e063-6394a90a9520

Reported adverse events (FAERS/openFDA)#

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