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Acetaminophen 325 Mg, Diphenhydramine Hcl 12.5 Mg, Phenylephrine Hcl 5 Mg

OTC Oral RxCUI 1233575
Contents

Overview

Active ingredient
Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Route
Oral
Label date
2025-11-07

Indications and usage

Uses temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes

Purpose

Pain reliever Antihistamine Nasal decongestant

Dosage and administration

Directions do not use more than directed adults and children 12 years and over: take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing 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 hives facial swelling asthma (wheezing) shock If a skin reaction occurs, stop use and seek medical help right away. 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. with any other product containing diphenhydramine, even one used on skin 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 acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

Ask a doctor before use if you have liver disease glaucoma thyroid disease heart disease diabetes high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages

Stop use and ask a doctor if

and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present

Pregnancy or breast-feeding

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

Active ingredient (label)

(in each liquid-filled capsule) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Inactive ingredients

s colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, povidone*, pregelatinized starch, stearic acid powder, talc, titanium dioxide *may contain these ingredients

Keep out of reach of children

of children . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222