Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID f762600a-f4b1-4869-a04b-8431c3d8a3e3
Route
ORAL
Published
Effective Date 2024-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (650 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Yellow No. 6 Propylene Glycol Water Trisodium Citrate Dihydrate Glycerin Saccharin Sodium Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum Acesulfame Potassium Alcohol Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-30
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

DAYTIME

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

NIGHTTIME

  •   temporarily relieves these common cold/flu symptoms` 
    • minor aches and pains
    • headache 
    • sore throat 
    • runny nose and sneezing
    • fever
    • cough due to minor throat and bronchial irritation
Warnings

DAYTIME

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

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.

NIGHTTIME

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.

Directions

DAYTIME

  • 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 



NIGHTTIME

  • 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.   
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing


Do Not Use

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Product Label
SIGNATURE CARE Daytime Cold & Flu Nighttime Cold & Flu Relief
Other Information

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains sodium 24 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

Day Time 

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

Night Time 

acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium trisodium citrate dihydrate

Purposes for Day Time

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments?

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

Principal Display Panel

DAYTIME

Compare to VICKS® DAYQUIL® Cold & Flu active ingredients*

Daytime

Cold & Flu Relief

ACETAMINOPHEN 325 mg - Pain Reliever / Fever Reducer)

DEXTROMETH HBr 10 mg - Cough Suppressant

PHENHYDRAMINE HCI 5 mg - Nasal Decongestant

ORIGINAL FLAVOR

  • Relieves aches, fever, sore throat, cough & nasal congestion
  • For ages 6 years & over
  • Non-drowsy
  • Alcohol free
  • Antihistamine free

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

NIGHT TIME

Compare to Vicks® NyQuil® Cold & Flu active ingredients*

Nighttime Cold & Flu Relief

ACETAMINOPHEN 650 mg - Pain Reliever / Fever Reducer)

DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine

CHERRY FLAVOR

  • Relieves Headache, fever, sore throat, minor aches & pains
  • Sneezing, runny nose, cough
  • For ages 12 years & over
  • Nighttime relief
  • Alcohol 10%

FL OZ (mL)

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

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

DISTRIBUTED BY BETTERLIVING BRANDS LLC

P.O. BOX99, PLEASANTON, VA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • 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
Stop Use and Ask A Doctor If

DAYTIME

  • 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.

NIGHTTIME

  • pain 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

DAYTIME NIGHTTIME

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.

Ask A Doctor Before Use If You Have

DAYTIME

  • liver disease
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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)

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
Active Ingredients  (in Each 15 Ml) Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Active Ingredients for (in Each 30 Ml) Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Structured Label Content

Uses

DAYTIME

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

NIGHTTIME

  •   temporarily relieves these common cold/flu symptoms` 
    • minor aches and pains
    • headache 
    • sore throat 
    • runny nose and sneezing
    • fever
    • cough due to minor throat and bronchial irritation
Warnings

DAYTIME

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

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.

NIGHTTIME

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.

Directions

DAYTIME

  • 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 



NIGHTTIME

  • 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.   
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing


Do Not Use (Do not use)

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Product Label
SIGNATURE CARE Daytime Cold & Flu Nighttime Cold & Flu Relief
Other Information (Other information)

DAYTIME

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

NIGHTTIME

  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains sodium 24 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

Day Time 

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

Night Time 

acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium trisodium citrate dihydrate

Purposes for Day Time

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

DAYTIME

Compare to VICKS® DAYQUIL® Cold & Flu active ingredients*

Daytime

Cold & Flu Relief

ACETAMINOPHEN 325 mg - Pain Reliever / Fever Reducer)

DEXTROMETH HBr 10 mg - Cough Suppressant

PHENHYDRAMINE HCI 5 mg - Nasal Decongestant

ORIGINAL FLAVOR

  • Relieves aches, fever, sore throat, cough & nasal congestion
  • For ages 6 years & over
  • Non-drowsy
  • Alcohol free
  • Antihistamine free

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

NIGHT TIME

Compare to Vicks® NyQuil® Cold & Flu active ingredients*

Nighttime Cold & Flu Relief

ACETAMINOPHEN 650 mg - Pain Reliever / Fever Reducer)

DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine

CHERRY FLAVOR

  • Relieves Headache, fever, sore throat, minor aches & pains
  • Sneezing, runny nose, cough
  • For ages 12 years & over
  • Nighttime relief
  • Alcohol 10%

FL OZ (mL)

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

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

DISTRIBUTED BY BETTERLIVING BRANDS LLC

P.O. BOX99, PLEASANTON, VA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product (When using this product)

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

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

DAYTIME

  • 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.

NIGHTTIME

  • pain 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.

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.)

DAYTIME NIGHTTIME

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.

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

DAYTIME

  • liver disease
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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)

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland
Active Ingredients  (in Each 15 Ml) Daytime (Active ingredients  (in each 15 mL) DAYTIME)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Active Ingredients for (in Each 30 Ml) Nighttime (Active ingredients for (in each 30 mL) NIGHTTIME)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:05.007276 · Updated: 2026-03-14T23:02:57.214195