Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID cc450f89-a156-48e0-82ae-19782f13c2ca

Route

ORAL

Published

Effective Date 2024-05-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

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

Inactive Ingredients

Anhydrous Citric Acid Fd&c Yellow No. 6 Glycerin Water Saccharin Sodium Trisodium Citrate Dihydrate Propylene Glycol Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-08-31

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves common cold/flu symptoms:

minor aches and pains
headache
sore throat
fever
nasal congestion
cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

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.

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.

Directions

do not take more than directed ((see Overdose warning)
do not take more than 4 doses in any 24-hours 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.

Product Label

SIGNATURE CARE Non-Drowsy Daytime Cold & Flu Relief

Other Information

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

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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Vicks® DayQuil® active ingredients*

Non-Drowsy

Day Time

Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever/fever reducer

Dextromethorphan HBr 10mg - Cough suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

ORIGINAL FLAVOR

Relieves aches, fever, sore throat, cough & nasal congestion
Alcohol free
Antihistamine free

For Ages 6 & Over

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Proctor & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA

94566-0009

www.betterlivingbrandsLLC.com

When Using This Product,

do not exceed recommended dosage.

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 last more than 3 days
redness or swelling is present
new symptom occur
cough comes back or occurs with rash or headache that lasts.

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.

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.

Active Ingredients (in Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
a sodium-restricted diet
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)

Ask A Doctor Or Pharmacist Before Use If

you are taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

minor aches and pains
headache
sore throat
fever
nasal congestion
cough due to minor throat and bronchial irritation

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

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.

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.

Directions

do not take more than directed ((see Overdose warning)
do not take more than 4 doses in any 24-hours 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.

Product Label

SIGNATURE CARE Non-Drowsy Daytime Cold & Flu Relief

Other Information (Other information)

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

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 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Vicks® DayQuil® active ingredients*

Non-Drowsy

Day Time

Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever/fever reducer

Dextromethorphan HBr 10mg - Cough suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

ORIGINAL FLAVOR

Relieves aches, fever, sore throat, cough & nasal congestion
Alcohol free
Antihistamine free

For Ages 6 & Over

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Proctor & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA

94566-0009

www.betterlivingbrandsLLC.com

When Using This Product, (When using this product,)

do not exceed recommended dosage.

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 last more than 3 days
redness or swelling is present
new symptom occur
cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

liver disease
heart disease
thyroid disease
diabetes
high blood pressure
a sodium-restricted diet
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)

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation", "Purpose": "Pain reliever/fever reducer Cough suppressant Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: 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. 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.", "Directions": "do not take more than directed ((see Overdose warning ) do not take more than 4 doses in any 24-hours 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.", "Product Label": "SIGNATURE CARE Non-Drowsy Daytime Cold & Flu Relief", "Other information": "each 15 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate", "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 1-888-723-3929 Monday-Friday 7AM-6PM PST ", "Principal Display Panel": "Compare to Vicks® DayQuil® active ingredients* Non-Drowsy Day Time Cold & Flu Relief Acetaminophen 325 mg - Pain reliever/fever reducer Dextromethorphan HBr 10mg - Cough suppressant Phenylephrine HCl 5 mg - Nasal Decongestant ORIGINAL FLAVOR Relieves aches, fever, sore throat, cough & nasal congestion Alcohol free Antihistamine free For Ages 6 & Over FL OZ (mL) *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Proctor & Gamble Company. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER THE CAP IS BROKEN OR MISSING . DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsLLC.com", "When using this product,": "do not exceed recommended dosage.", "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 last more than 3 days redness or swelling is present new symptom occur cough comes back or occurs with rash or headache that lasts. 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.": "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.", "Active ingredients (in each 15 mL)": "Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg", "Ask a doctor before use if you have": "liver disease heart disease thyroid disease diabetes high blood pressure a sodium-restricted diet 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)", "Ask a doctor or pharmacist before use if": "you are taking the blood thinning drug warfarin."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:04.925489 · Updated: 2026-03-14T23:02:57.214195