FDA Label for Pentrexcilina Children Total Relief Multi-symptom
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pentrexcilina Children Total Relief Multi-symptom Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
in each 10mL 2 teaspoonful
Acetaminophen 250mg
Dextromethorphan HBr 13.33mg
Guaifenesin USP 200mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal descongestant
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 promtoes 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
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 |
| Children 6 to under 12 years of age | 10 mL or 2 tsp provided every 4 hours |
| Children under 6 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 70% USP, sucralose.
Questions?
Call 619-600-5632 MN to FRI, 9 a.m. to 6 p.m. PTZ
Package Label.Principal Display Panel
MAXIMUM STRENGHT
NDC 69729-789-06
PENTREXCILINA
TOTAL RELIEF
ACETAMINOPHEN
DEXTROMETORPHAN HBr
PHENYLEPHRINE HCl
GUAIFENESIN
CHILDREN
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
* Please review the disclaimer below.
