Tesalon Multi Symptom Relief

Tesalon Multi Symptom Relief
SPL v2
SPL
SPL Set ID 231c6455-4198-feec-e063-6394a90a8541
Route
ORAL
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (26.66 mg) Phenylephrine (10 mg) Guaifenesin (400 mg)
Inactive Ingredients
Aloe Anhydrous Citric Acid Hydroxyethyl Cellulose, Unspecified Sorbitol Solution Edetate Disodium Fd&c Red No. 4 Propylene Glycol Water Sodium Benzoate Sucralose

Identifiers & Packaging

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

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

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 51945-4

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

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

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

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.

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.

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

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, 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

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.

Keep Out of Reach of Children

Keep out of reach of children

If Pregnant Or Breast Feeding,

ask health professional before use

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

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 51945-4 (51945-4)

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

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

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

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.

Liver Warning (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 (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.

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

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, purified water, sodium benzoate, sorbitol solution, sucralose.

Questions Or Comments? (Questions or comments?)

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

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.

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

Keep out of reach of children

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask health professional before use

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.


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