Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1de2a7fd-129e-4b7b-a9bf-7a5811367bbf
Route
ORAL
Published
Effective Date 2025-08-18
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) Guaifenesin (200 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide Mannitol Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 12A Shape: capsule Color: green Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-10-30 Until 2026-12-30

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

DAYTIME

  • temporarily relieves
    • nasal congestion
    • headache
    • cough
    • sinus congestion and pressure
    • minor aches and pains
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

NIGHTTIME

  • temporarily relieves
    • nasal congestion
    • cough
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • runny nose and sneezing
  • temporarily promotes nasal and/or sinus drainage
Warnings

DAYTIME and 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 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

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing 
Do Not Use

DAYTIME and 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 HEALTH Maximum Strength Daytime Nighttime Sinus Relief
Other Information

DAYTIME and NIGHTTIME

  • swallow whole; do not crush, chew, or dissolve
  • store between 15-30ºC (59-86F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients

DAYTIME

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

NIGHTTIME

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



Purpose for Nighttime

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Questions Or Comments?

DAYTIME and NIGHTTIME

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night Liquid Gel*

MAXIMUM STRENGTH

DAYTIME

Sinus Relief

ACETAMINOPHEN - 325 mg Pain reliever

DEXTROMETHORPHAN HBr - 10 mg Cough suppressant

GUAIFENESIN - 200 mg Expectorant

PHENYLEPHRINE HCL - 5 mg Nasal decongestant

  • Relieves sinus pressure, headache & congestion
  • Controls cough
  • thins & loosens mucus

FOR AGES 12 YEARS & OLDER

Alcohol Free

SOFTGELS**

MAXIMUM STRENGTH

NIGHTTIME

Sinus Relief

ACETAMINOPHEN - 325 mg Pain reliever

DEXTROMETHORPHAN HBr - 10 mg Cough suppressant

DOXYLAMINE SUCCINATE - 6.25 mg Antihistamine

PHENYLEPHRINE HCL - 5 mg Nasal decongestant

  • Relieves nasal congestion, sinus pressure & pain
  • Controls cough
  • Controls runny nose and sneezing

FOR AGES 12 YEARS & OLDER

Alcohol Free

SOFTGELS*

(**Liquid-filled capsules)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.Liquid Gels.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY 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 use more than directed

NIGHTTIME

  • do not use more than directed
  • 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 and NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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 coukld be signs of a serious condition.
If Pregnant Or Breast Feeding,

DAYTIME and NIGHTTIME

ask a health professional before use.

Keep Out of Reach of Children.

DAYTIME and NIGHTTIME

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

NIGHTTIME

  • liver disease
  • high blood pressure
  • diabetes
  • heart disease
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • breathing problem s such as emphysema or chronic bronchitis
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)  
Active Ingredients in Daytime (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 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 in Nighttime (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg


Structured Label Content

Uses

DAYTIME

  • temporarily relieves
    • nasal congestion
    • headache
    • cough
    • sinus congestion and pressure
    • minor aches and pains
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

NIGHTTIME

  • temporarily relieves
    • nasal congestion
    • cough
    • headache
    • sinus congestion and pressure
    • minor aches and pains
    • runny nose and sneezing
  • temporarily promotes nasal and/or sinus drainage
Warnings

DAYTIME and 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 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

Directions

DAYTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

NIGHTTIME

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing 
Do Not Use (Do not use)

DAYTIME and 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 HEALTH Maximum Strength Daytime Nighttime Sinus Relief
Other Information (Other information)

DAYTIME and NIGHTTIME

  • swallow whole; do not crush, chew, or dissolve
  • store between 15-30ºC (59-86F)
  • avoid excessive heat
Purpose for Daytime

Pain reliever

Cough suppressant

Expectorant

Nasal decongestant

Inactive Ingredients (Inactive ingredients)

DAYTIME

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitiol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

NIGHTTIME

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



Purpose for Nighttime

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Questions Or Comments? (Questions or comments?)

DAYTIME and NIGHTTIME

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night Liquid Gel*

MAXIMUM STRENGTH

DAYTIME

Sinus Relief

ACETAMINOPHEN - 325 mg Pain reliever

DEXTROMETHORPHAN HBr - 10 mg Cough suppressant

GUAIFENESIN - 200 mg Expectorant

PHENYLEPHRINE HCL - 5 mg Nasal decongestant

  • Relieves sinus pressure, headache & congestion
  • Controls cough
  • thins & loosens mucus

FOR AGES 12 YEARS & OLDER

Alcohol Free

SOFTGELS**

MAXIMUM STRENGTH

NIGHTTIME

Sinus Relief

ACETAMINOPHEN - 325 mg Pain reliever

DEXTROMETHORPHAN HBr - 10 mg Cough suppressant

DOXYLAMINE SUCCINATE - 6.25 mg Antihistamine

PHENYLEPHRINE HCL - 5 mg Nasal decongestant

  • Relieves nasal congestion, sinus pressure & pain
  • Controls cough
  • Controls runny nose and sneezing

FOR AGES 12 YEARS & OLDER

Alcohol Free

SOFTGELS*

(**Liquid-filled capsules)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Sinus-Max® Day and Maximum Strength Mucinex® Sinus-Max® Night.Liquid Gels.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY 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 use more than directed

NIGHTTIME

  • do not use more than directed
  • 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 and NIGHTTIME

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, 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 coukld be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

DAYTIME and NIGHTTIME

ask a health professional before use.

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

DAYTIME and NIGHTTIME

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

NIGHTTIME

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 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 in Nighttime (in Each Softgel) (Active ingredients in Nighttime (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg


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