Purposes
| Active ingredients (in each 20mL) | Purposes |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 26.66 mg | Cough suppressant |
| Guaifenesin USP 400 mg | Expectorant |
| Phenylephrine Cl 10 mg | Nasal decongestant |
Tesalon Jarabe Adulto Syrup
FDA Label NDC 69729-787
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Tesalon Jarabe Adulto (NDC 69729-787). 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 purposes, uses, liver warning, allergy allert, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 Allert
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.
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
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
Age.............................. Dose
Adults and children 12 years of age and older 20 mL in dosing cup provided every 4 hours
Children under 12 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, purified water, sodium benzoate, sorbitol solution, sucralose.
Questions Or Comments?
Call 619-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ
Package Label.Principal Display Panel
NDC 69729-787-06
Tesalon®
Alivia Múltiples-Síntomas
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 69729-787-06
Tesalon®
Multi-Sympton Relief
Cold, Flu & Sore Throat
Maximum Strength
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
Tampering evident: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
VERSIÓN EN ESPAÑOL EN EL INTERIOR DE LA CAJA
* Please review the disclaimer below.
