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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Tesalon Children (NDC 69729-786). 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 other, active ingredients, purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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
| 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:
This product contains acetaminophen.
Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
These could be signs of a serious condition.
ask health professional before use
.
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.
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
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.
Call 619-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ
NDC 69729-786-06
Tesalon®
Infantil
Gripe, Resfriado & Garganta Irritada
Máxima Potencia
(Acetaminophen)
(Dextromethorphan HBr)
(Guaifenesin)
(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
(Acetaminophen)
(Dextromethorphan HBr)
(Guaifenesin)
(Phenylephrine HCl)
Relief up to 8 hours
Box with bottle of 6 FL OZ (177mL)
and measuring cup
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