DRUG FACTS

Manufacturer
CVS Pharmacy
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:06

Label at a glance#

ProductDayTime Severe Congestion Relief and Nighttime Severe Cough and Congestion Relief Maximum Strength
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Nighttime temporarily relieves headache nasal congestion minor aches and pains cough sinus congestion and pressure  runny nose and sneezing temporarily promotes nasal and/or sinus drainage  controls cough to help you get to sleep Daytime temporarily relieves headache nasal congestion minor aches and pains sinus congestion and pressure temporarily promotes nasal and/or sinus drainage  helps loosen phlegm (mucus) an...

Dosage and administration

Nighttime do not take more than directed (see overdose warning ) do not take more than 6 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 = mililiter dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use Daytime do not t...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients for Nighttime (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg

Phenylephrine HCI 10 mg 

Active ingredients for Daytime (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Guaifeenesin 400 mg

Phenylephrine HCl 10 mg

Purpose for Nighttime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Purpose for Daytime

OTC - PURPOSE SECTION

Pain reliever

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Nighttime

  • temporarily relieves
    • headache
    • nasal congestion
    • minor aches and pains
    • cough
    • sinus congestion and pressure 
    • runny nose and sneezing
    • temporarily promotes nasal and/or sinus drainage 
    • controls cough to help you get to sleep

Daytime

  • temporarily relieves
    • headache
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure
    • 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 cough more productive

Warnings

WARNINGS SECTION

NIGHTTIME and DAYTIME

 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.

Do not use

OTC - DO NOT USE SECTION

Nighttime

  • with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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
  • for children under 12 years of age

Daytime

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Nighttime

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem 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)

Daytime

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Nighttime

  • you are taking the blood thinning drug warfarin
  • you are taking sedative or tranquilizers

Daytime

  • taking the blood thinning drug warfarin

When using these products

OTC - WHEN USING SECTION

Nighttime

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicile or operating machinery

Daytime

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

Nighttime

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or last 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 a signs of a serious condition

 Daytime

  • 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 could be signs of a serious condition. 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Nighttime and DayTime

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Nighttime and DayTime

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Nighttime

  • do not take more than directed (see overdose warning)
  • do not take more than 6 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 = mililiter
  • dose as follows or as directed by a doctor
  • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
  • children under 12 years of age: do not use

Daytime

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • dose as follows or as directed by a doctor 
  • keep dosing cup with product 
  • mL = milliliter
  • adults and children 12 years of age and older: 20 mL every 4 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

Nighttime

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

Daytime

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nighttime

citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Daytime

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Nighttime and DayTime

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIGHTTIME

Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX®  Night Time Congestion & Cough*

NIGHTTIME

Severe Cough & Congestion Relief

ACETAMINOPHEN - Pain reliever

DIPHENHYDRAMINE HCI - Antihistamine; Cough suppressant

PHENYLEPHRINE HCI - Nasal decongestant

MAXIMUM STRENGTH

Multi-Symptom

  • Clears sinus congestion
  • Relieves headache
  • Relieves runny nose & sneezing

For Ages 12 & Over

DAYTIME

Compare to the active ingredients in Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief*

ADULT Severe Congestion Relief

ACETAMINOPHEN - Pain reliever

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCI - Nasal decongestion

MAXIMUM STRENGTH

Multi-symptom

  • Clear sinus congestion
  • relieves headache
  • Thins & loosens mucus 

For Ages 12 & over

FL OZ (mL)

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

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief & Night Time Congestion & Cough. 

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-93969842-939-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fe5cdffc-7cb6-4905-a4ee-5abe87118d88bc0bdb0a-80cb-44fa-bb3e-b77508f63d8c2023-01-18WarningsExact identifier
spl id: fe5cdffc-7cb6-4905-a4ee-5abe87118d88
spl set id: bc0bdb0a-80cb-44fa-bb3e-b77508f63d8c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.