FDA Label for Tesalon Children

View Indications, Usage & Precautions

Tesalon Children Product Label

The following document was submitted to the FDA by the labeler of this product Opmx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredients

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

Active ingredients (in each 10 mL=2 teaspoonful)	Purposes
Acetaminophen 250 mg	Pain reliever/fever reducer
Dextromethorphan HBr 13.33mg	Cough suppressant
Guaifenesin USP 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

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

Liver Warning

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

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

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

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

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

taking the blood thinning drug warfarin
taking sodium restricted diet

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

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

ask health professional before use

Keep Out Of Reach Of Children

Overdose Warning

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

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

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

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?

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

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