FDA Label for Pentrexcilina Daytime
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pentrexcilina Daytime 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.
Otc - Active Ingredient
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
Otc - Purpose
PURPOSE
Pain Reliever/Fever Reducer
Antihistamine
Nasal decongestant
Indications & Usage
Uses:
- temporarily relieves these symptoms of hay fever or other respiratory allergies:
- headache
- sinus congestion & pressure
- nasal congestion
- runny nose and sneezing
- minor aches & pain
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus opening and passages
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take :
- more than 6 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs contains acetaminophen
- 3 or more alcoholic drinks every day while using this product.
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 doctor promptly
Otc - 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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- to make a child sleepy
Otc - Ask Doctor
Ask a doctor before use if you have:
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Otc - When Using
When using this product:
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if:
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or last more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding: ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: Taking more tahn directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions:
- Do not take more than directed - see overdose warning
- Swallow whole; do not crush, chew or dissolve
- Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over | 1 tablet with water every 4-6 hours as needed |
Children 4 to 12 years of age | Ask a doctor |
Children under 4 years of age | Do not use |
Storage And Handling
Other information:
- Store at room temperature between 20-25°C (68-77°F)
- Avoid excessive heat and humidity
Inactive Ingredient
Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrollidone, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, Purified Talc
Otc - Questions
Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
Other
TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Exclusively distributed by:
OPMX
San Diego, CA 92154
Phone: 619-600-5632
Package Label.Principal Display Panel
READ AND KEEP CARTON FOR COMPLETE PRODUCT INFORMATION
Drug Facts
COLD & FLU
NDC 69729-223-38
DAYTIME
Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg
PENTREXCILINA
Effective and Quick Relief from cold & flu symptoms
- Headache
- Nasal Congestion
- Itchy, Watery Eyes
- Runny Nose & Sneezing
144 Tablets (72 Pouches of 2 tablets)
* Please review the disclaimer below.