Package Label

Package Label
SPL v4
SPL
SPL Set ID dc315218-bdd9-44b4-ab0a-71077fe0a73c
Route
ORAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Acetaminophen 650 mg  Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

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. 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.

Indications and Usage

temporarily relieves these common cold/flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep

Dosage and Administration

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use

Description

Acetaminophen 650 mg  Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Section 44425-7

each 20 mL contains : Sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Section 50565-1

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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 rash or headache that lasts. These could be signs of a serious condition.

Section 50567-7

do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness

Section 50568-5

the blood thinning drug warfarin  sedatives or tranquilizers

Section 50569-3

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

Section 50570-1

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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other drug containing diphenhydramine, even one used on the skin for children under 12 years of age

Section 51727-6

citric acid, disodium EDTA, FD & C blue #1, FD & C red #40, flavor, glycerin, propyl gallate,  propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu* MAXIMUM STRENGTH NIGHT TIME COLD & FLU MULTI-SYMPTOM RELIEF PAIN RELIEVER / FEVER REDUCER ANTIHISTAMINE / COUGH SUPPRESSANT NASAL DECONGESTANT ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HCl 25 mg PHENYLEPHRINE HCl 10 MG Temporarily relieves aches,fever, sore throat, nasal congestion, runny nose & sneezing Controls cough For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor or Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53414-9

ask a health professional before use.

Section 55105-1

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Section 55106-9

Acetaminophen 650 mg  Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves these common cold/flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep

Dosage and Administration (34068-7)

do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use

Warnings and Precautions (34071-1)

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. 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.

Section 44425-7 (44425-7)

each 20 mL contains : Sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Section 50565-1 (50565-1)

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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 rash or headache that lasts. These could be signs of a serious condition.

Section 50567-7 (50567-7)

do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

the blood thinning drug warfarin  sedatives or tranquilizers

Section 50569-3 (50569-3)

liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

Section 50570-1 (50570-1)

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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other drug containing diphenhydramine, even one used on the skin for children under 12 years of age

Section 51727-6 (51727-6)

citric acid, disodium EDTA, FD & C blue #1, FD & C red #40, flavor, glycerin, propyl gallate,  propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu* MAXIMUM STRENGTH NIGHT TIME COLD & FLU MULTI-SYMPTOM RELIEF PAIN RELIEVER / FEVER REDUCER ANTIHISTAMINE / COUGH SUPPRESSANT NASAL DECONGESTANT ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HCl 25 mg PHENYLEPHRINE HCl 10 MG Temporarily relieves aches,fever, sore throat, nasal congestion, runny nose & sneezing Controls cough For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor or Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 650 mg  Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg


Raw Label Data

All Sections (JSON)