Daytime Cold & Flu, Lil' Drug Store ®

SPL v7

SPL

SPL Set ID fd5c20ed-5520-4db0-bfd4-995f043af2a4

Route

ORAL

Published

Effective Date 2017-11-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Yellow No. 6 Glycerin Polyethylene Glycol, Unspecified Sucrose Sodium Citrate, Unspecified Form Saccharin Sodium Water Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-01

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not exceed recommended dosage.

Section 50568-5

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

Section 53414-9

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

Section 55105-1

Active ingredients (in each 15 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Warnings

Warnings

Directions

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.
keep dosing cup with product
mL = milliliter

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 other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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.

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.

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 every day while using this product

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.

Other Information

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

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.

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
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.

Ask A Doctor Before Use If You Have

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

Principal Display Panel 237 Ml Bottle Label

[Quality Guaranteed caduceus]

Compare to the Active

Ingredients in Vicks ^®

DayQuil™ Cold & Flu*

Non-Drowsy

Cold & Flu

Daytime

Acetaminophen, 325 mg,

Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg, Cough Supressant

Phenylephrine HCl 5 mg, Nasal Decongestant

Relieves

• Sore Throat • Aches

• Fever • Cough

• Nasal Congestion

For ages 6 years and over

8 FL OZ

(237 mL)

[Lil' Drug Store logo]

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not exceed recommended dosage.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each 15 mL)	Purposes
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Warnings

Warnings

Directions

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.
keep dosing cup with product
mL = milliliter

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 other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Do Not Use (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.

Allergy Alert (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.

Liver Warning (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 every day while using this product

Overdose Warning (Overdose warning)

Other Information (Other information)

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

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

[Quality Guaranteed caduceus]

Compare to the Active

Ingredients in Vicks ^®

DayQuil™ Cold & Flu*

Non-Drowsy

Cold & Flu

Daytime

Acetaminophen, 325 mg,

Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg, Cough Supressant

Phenylephrine HCl 5 mg, Nasal Decongestant

Relieves

• Sore Throat • Aches

• Fever • Cough

• Nasal Congestion

For ages 6 years and over

8 FL OZ

(237 mL)

[Lil' Drug Store logo]

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus congestion cough due to minor throat and bronchial irritation", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product, do not exceed recommended dosage.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 15 mL) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant", "Warnings": "Warnings", "Directions": "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. keep dosing cup with product mL = milliliter 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 other Daytime or Nighttime products, carefully read each label to ensure correct dosing", "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.", "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.", "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 every day while using this product", "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.", "Other information": "each 15 mL contains: sodium 12 mg store between 20-25°C (68-77°F). Do not refrigerate.", "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.", "Inactive ingredients": "citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum", "Questions or comments?": "Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)", "PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label": "[Quality Guaranteed caduceus] Compare to the Active Ingredients in Vicks ® DayQuil™ Cold & Flu* Non-Drowsy Cold & Flu Daytime Acetaminophen, 325 mg, Pain Reliever/Fever Reducer Dextromethorphan HBr 10 mg, Cough Supressant Phenylephrine HCl 5 mg, Nasal Decongestant Relieves • Sore Throat • Aches • Fever • Cough • Nasal Congestion For ages 6 years and over 8 FL OZ (237 mL) [Lil' Drug Store logo]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.107924 · Updated: 2026-03-14T23:11:00.469021