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Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl

OTC RxCUI 1046378
Contents

Overview

Label date
2025-12-02

Indications and usage

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: nasal congestion headache minor aches and pains sinus congestion and pressure runny nose and sneezing (Nighttime only) promotes sinus drainage helps clear nasal passages helps decongest sinus openings and passages temporarily reduces fever

Purpose

Pain reliever/fever reducer Nasal decongestant

Pain reliever/fever reducer Antihistamine Nasal decongestant

Dosage and administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve 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 If a skin reaction occurs, stop use and seek medical help right away. Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. Ask a doctor before use if you have heart disease high blood pressure liver disease thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage use caution when driving a motor vehicle or operating machinery (Nighttime only) drowsiness may occur (Nighttime only) excitability may occur, especially in children (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) 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 lasts 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. In case of accidental 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. Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients 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.

Ask a doctor before use if

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

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 (Nighttime only)

When using this product

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

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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (in each caplet) (Daytime Sinus Congestion & Pain) Acetaminophen 325 mg Phenylephrine HCl 5 mg

s (in each caplet) (Nighttime Sinus Congestion & Pain) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Inactive ingredients

s (Daytime only) corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

s (Nighttime only) corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Storage and handling

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

Keep out of reach of children

of children. In case of accidental 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. Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.