Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID a8df5c04-0f92-4013-b3e5-2b45009a7b8d
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 (15 mg) Doxylamine (6.25 mg) Phenylephrine (10 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Mannitol Butylated Hydroxyanisole Butylated Hydroxytoluene Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: P19 Shape: oval Shape: capsule Color: green Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-30
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
    • cough due to minor throat and bronchial irritation 
    • nasal congestion
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

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

DAYTIME

Liver warning: These products contain 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 these products

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 contain 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 following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over; take 2 softgels with water every 4 hours
  • children under 12 years: do not use

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use
Do Not Use

DAYTIME

  • 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.

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 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 Daytime Nighttime Cold and Flu Relief
Other Information
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Inactive Ingredients

DAYTIME

 butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-6PM EST

Principal Display Panel

DAYTIME

Compare to Vicks® DayQuil® Cold & Flu LiquiCaps® active ingredients†

Non-Drowsy Daytime Cold & Flu Relief

ACETAMINOPHEN 325 mg - Pain Reliever/Fever Reducer

DEXTROMETHORPHAN HBr 10 mg - Cough Suppressant 

PHENYLEPHRINE HCL 5 mg - Nasal Decongestant

Relieves

  • Aches, Fever, Sore Throat
  • Cough
  • Nasal Congestion

Alcohol-Free

Antihistamine-Free

SOFTGELS**

(**Liquid-Filled Capsules)

NIGHTTIME

Compare to Vicks® NyQuil® Cold & Flu LiquiCaps® active ingredients†

Nighttime Cold & Flu Relief

ACETAMINOPHEN 325 mg -  Pain Reliever/Fever Reducer 

DEXTROMETHORPHAN HBr 15 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 6.25 mg - Antihistamine 

Relieves

  • Aches, Fever, Sore Throat
  • Cough
  • Runny Nose, Sneezing

Alcohol-Free

SOFTGELS

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99 PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product,

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur 
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that last.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 headache that lasts.These could be a 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 can 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

NIGHTTIME

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

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

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Structured Label Content

Uses

DAYTIME

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

NIGHTTIME

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

DAYTIME

Liver warning: These products contain 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 these products

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 contain 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 following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over; take 2 softgels with water every 4 hours
  • children under 12 years: do not use

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use
Do Not Use (Do not use)

DAYTIME

  • 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.

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 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 Daytime Nighttime Cold and Flu Relief
Other Information (Other information)
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

DAYTIME

 butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-6PM EST

Principal Display Panel

DAYTIME

Compare to Vicks® DayQuil® Cold & Flu LiquiCaps® active ingredients†

Non-Drowsy Daytime Cold & Flu Relief

ACETAMINOPHEN 325 mg - Pain Reliever/Fever Reducer

DEXTROMETHORPHAN HBr 10 mg - Cough Suppressant 

PHENYLEPHRINE HCL 5 mg - Nasal Decongestant

Relieves

  • Aches, Fever, Sore Throat
  • Cough
  • Nasal Congestion

Alcohol-Free

Antihistamine-Free

SOFTGELS**

(**Liquid-Filled Capsules)

NIGHTTIME

Compare to Vicks® NyQuil® Cold & Flu LiquiCaps® active ingredients†

Nighttime Cold & Flu Relief

ACETAMINOPHEN 325 mg -  Pain Reliever/Fever Reducer 

DEXTROMETHORPHAN HBr 15 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 6.25 mg - Antihistamine 

Relieves

  • Aches, Fever, Sore Throat
  • Cough
  • Runny Nose, Sneezing

Alcohol-Free

SOFTGELS

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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,)

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur 
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that last.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 headache that lasts.These could be a 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.)

Overdose warning: Taking more than the recommended dose can 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

NIGHTTIME

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland
Active Ingredients for Daytime (in Each Softgel) (Active ingredients for Daytime (in each softgel))

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 the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Active Ingredients for Nighttime (in Each Softgel) (Active ingredients for Nighttime (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.985736 · Updated: 2026-03-14T23:02:57.214195