Package Label

Package Label
SPL v6
SPL
SPL Set ID c1bc7671-943f-4322-bc11-84ea17025bd1
Route
ORAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg


Medication Information

Warnings and Precautions

Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount. child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allery 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 common cold and flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Dosage and Administration

do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours  children 6 to under 12 years   15 mL every 4 hours  children 4 to under 6 years   ask a doctor  children under 4 years do not use  When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Description

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg

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) immediately. 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

redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs, with rash or headache that lasts. These could be signs of a serious condition.

Section 50567-7

do not exceed recommended dosage .

Section 50568-5

you are taking the blood thinning drug warfarin.

Section 50569-3

liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland

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.

Section 51727-6

citric acid, FD & C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4

*Compare to the active ingredients of Vicks® DayQuil® Cold & Flu RELIEVES Aches Fever & Sore Throat Cough Nasal Congestion Non-Drowsy Multi-Symptom Daytime Cold & Flu RELIEF Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 10 mg  Cough suppressant Phenylephrine HCl 5 mL Nasal decongestant For ages 6 years and over Alcohol-free Antihistamine-free FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. DISTRIBUTED BY: Lidl US, LLC 3500 S. Clark Street Arlington, VA 22202 www.lidl.com

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

ask a health professional before use.

Section 55105-1

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Section 55106-9

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg

Section 60561-8

each 15 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation

Dosage and Administration (34068-7)

do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours  children 6 to under 12 years   15 mL every 4 hours  children 4 to under 6 years   ask a doctor  children under 4 years do not use  When using Day Time and Night Time products, carefully read each label to ensure correct dosing

Warnings and Precautions (34071-1)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount. child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allery 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 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) immediately. 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)

redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 exceed recommended dosage .

Section 50568-5 (50568-5)

you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland

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.

Section 51727-6 (51727-6)

citric acid, FD & C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Section 51945-4 (51945-4)

*Compare to the active ingredients of Vicks® DayQuil® Cold & Flu RELIEVES Aches Fever & Sore Throat Cough Nasal Congestion Non-Drowsy Multi-Symptom Daytime Cold & Flu RELIEF Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 10 mg  Cough suppressant Phenylephrine HCl 5 mL Nasal decongestant For ages 6 years and over Alcohol-free Antihistamine-free FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by The Procter & Gamble Company.Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company. DISTRIBUTED BY: Lidl US, LLC 3500 S. Clark Street Arlington, VA 22202 www.lidl.com

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg

Section 60561-8 (60561-8)

each 15 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate


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