Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID df6e522c-3e30-4aa0-8ab9-3b579c80bcad
Route
ORAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Lecithin, Soybean Light Mineral Oil Mannitol Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: capsule Color: green Color: orange Size: 21 mm Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-31
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

DAYTIME

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

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 NIGHTTIME

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.

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 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
CVS Daytime Nighttime Cold & 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

FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, 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-5PM EST

Principal Display Panel

Compare to Vicks® DayQuil™ and NyQuil™ Cold & Flu LiquiCaps™active ingredients*

DAYTIME

COLD & FLU

Acetaminophen 

Pain reliever; Fever reducer

Dextromethorphan HBr

Cough suppressant

Phenylephrine HCI Nasal decongestant

Multi-Symptom Relief

Aches, Fever, Sore throat, Cough, Nasal congestion, Sinus Pressure

SOFTGELS**

NIGHTTIME

COLD & FLU

Acetaminophen 

Pain reliever; Fever reducer

Dextromethorphan HBr

Cough suppressant

Doxylamine Succinate

Antihistamine

Multi-Symptom Relief

Aches, Fever, Sore throat, Cough, Sneezing; Runny nose

SOFTGELS**

(**Liquid filled capsules)

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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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, and 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 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 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 
    • fever
    • sore throat
    • nasal congestion and sinus pressure
    • headache
    • minor aches and pain

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 NIGHTTIME

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.

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 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
CVS Daytime Nighttime Cold & 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

FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, 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-5PM EST

Principal Display Panel

Compare to Vicks® DayQuil™ and NyQuil™ Cold & Flu LiquiCaps™active ingredients*

DAYTIME

COLD & FLU

Acetaminophen 

Pain reliever; Fever reducer

Dextromethorphan HBr

Cough suppressant

Phenylephrine HCI Nasal decongestant

Multi-Symptom Relief

Aches, Fever, Sore throat, Cough, Nasal congestion, Sinus Pressure

SOFTGELS**

NIGHTTIME

COLD & FLU

Acetaminophen 

Pain reliever; Fever reducer

Dextromethorphan HBr

Cough suppressant

Doxylamine Succinate

Antihistamine

Multi-Symptom Relief

Aches, Fever, Sore throat, Cough, Sneezing; Runny nose

SOFTGELS**

(**Liquid filled capsules)

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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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, and 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 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 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: 2026-02-15T12:07:03.760113 · Updated: 2026-03-14T23:13:20.000214