OTC Medication Information: Pentrexcilina Daytime

PENTREXCILINA DAYTIME- phenylephrine hydrochloride, acetaminophen and chlorpheniramine maleate tablet
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

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

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.

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 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
• 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

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

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

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

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.

If pregnant or breast-feeding: ask a health professional before use.

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.

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

Other information:

• Store at room temperature between 20-25°C (68-77ºF)
• Avoid excessive heat and humidity

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrollidone, Crospovidone, Magnesium Stearate, Colloidal Silicon Dioxide, Purified Talc

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

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

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)

PENTREXCILINA DAYTIME acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-223 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSPOVIDONE TALC SILICON DIOXIDE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED

Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor Imprint Code A15 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69729-223-38 72 POUCH in 1 CARTON contains a POUCH 1 2 TABLET in 1 POUCH This package is contained within the CARTON (69729-223-38)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2020

Labeler — OPMX LLC (029918743)

Revised: 03/2022 OPMX LLC