Tesalon Children Multi-symptom

Tesalon Children Multi-symptom
SPL v1
SPL
SPL Set ID 2309620a-ccbc-41e9-e063-6394a90a9520
Route
ORAL
Published
Effective Date 2024-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (13.33 mg) Phenylephrine (5 mg) Acetaminophen (250 mg)
Inactive Ingredients
Sorbitol Solution 70% Sodium Benzoate Hydroxyethyl Cellulose, Unspecified Anhydrous Citric Acid Fd&c Red No. 40 Water Edetate Disodium Aloe Propylene Glycol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-27

Description

Drug Facts

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


Medication Information

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

Description

Drug Facts

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
Section 42229-5

Drug Facts

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

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.
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.

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
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.

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
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

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.

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

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

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

.

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

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

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

Do Not Use (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.
Allergy Alert (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.

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
Overdose Warning (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.

Other Information (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
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

Sore Throat Warning (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.

Inactive Ingredients (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? (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

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

When Using This Product (When using this product)
  • do not exceed recommended dose (see overdose warning)
Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask health professional before use

Keep Out of Reach of Children (Keep out of reach of children)

.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sodium restricted diet

Advanced Ingredient Data


Raw Label Data

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