PENTREXCILINA ADULT TOTAL RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide, guaifenesin usp, phenylephrine hydrochloride syrup

Pentrexcilina Adult TOTAL RELIEF Multi-Symptom by

Drug Labeling and Warnings

Pentrexcilina Adult TOTAL RELIEF Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Active ingredients

Purpose

• Active ingredients (in each 10mL=2 teaspoonful): Purpose
• Acetaminophen 500 mg: Pain reliever/ fever reducer
• Dextromethorphan HBr 26.66 mg: Cough suppressant
• Guaifenesin 400 mg: Expectorant
• Phenylephrine HCl 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 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.

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 Parkinson´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

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 a 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 sings or symptms.

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=mililiter
• 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 USP, purified water, sodium benzoate, sorbitol solution, sucralose.

Questions?

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

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGHT

NDC: 69729-790-06

PENTREXCILINA

TOTAL RELIEF

ACETAMINOPHEN

DEXTROMETORPHAN HBr

PHENYLEPHRINE HCl

GUAIFENESIN

Flu

Cold &

Cough

• FEVER
• BODYACHE
• HEADACHE
• SORE THROAT

6fl oz (177ml)

VERSIÓN EN ESPAÑOL EN EL INTERIOR DE LA CAJA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Manufactured in FDA Registered in the USA

INGREDIENTS AND APPEARANCE

PENTREXCILINA ADULT TOTAL RELIEF MULTI-SYMPTOM 
acetaminophen, dextromethorphan hydrobromide, guaifenesin usp, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-790
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-790-06	1 in 1 CARTON	01/15/2025
1		177 mL in 1 BOTTLE; 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	01/15/2025

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(69729-790)