TESALON JARABE ADULTO- acetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl syrup

Tesalon Jarabe Adulto by

Drug Labeling and Warnings

Tesalon Jarabe Adulto by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

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

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

Warnings

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

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

INGREDIENTS AND APPEARANCE

TESALON JARABE ADULTO 
acetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-787
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	26.66 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-787-06	1 in 1 CARTON	09/27/2024
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/27/2024

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(69729-787)