Pentrexcilina Adult Total Relief Multi-symptom

Pentrexcilina Adult Total Relief Multi-symptom
SPL v1
SPL
SPL Set ID 2bef3b6f-456a-5b76-e063-6394a90aa116
Route
ORAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Acetaminophen (500 mg) Dextromethorphan (26.66 mg) Guaifenesin (400 mg)
Inactive Ingredients
Edetate Disodium Fd&c Red No. 40 Hydroxyethyl Cellulose, Unspecified Propylene Glycol Aloe Vera Whole Anhydrous Citric Acid Sorbitol Solution Sucralose Water Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

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


Medication Information

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

Description

Active ingredients

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

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

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

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.
Questions?

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

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 sings or symptms.

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

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 solution, sucralose.

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

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)

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

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

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

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 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.
Questions?

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

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 (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 sings or symptms.

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)

Active ingredients

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 solution, sucralose.

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 a health professional before use.

Keep Out of Reach of Children (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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