FDA.reportPublic FDA data

DRUG FACTS

Manufacturer
Walgreens
Effective date
2026-08-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-01 13:01:55

Label at a glance#

ProductDaytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Nighttime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep Daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive temporarily relieves cough due to minor throat 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 : 17 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

Dextromethorphan HBr 20 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

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Nighttime

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing 
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold

Warnings

WARNINGS SECTION

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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

  • 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. 
  • for children under 12 years of age

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

  • 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

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

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
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occur with fever, 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

ask a health professional before use.

Daytime

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Nighttime

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.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = mililiter
  • shake well before using
  • adults and children 12 years of age and older: 20 mL in dosing cup provided 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: 17 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

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

Daytime

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough & Night Time Cold & Flu active ingredient††

NIGHTTIME

Cold & Flu

ACETAMINOPHEN  /

PAIN RELIEVER & FEVER REDUCER

DIPHENHYDRAMINE HCI /

ANTIHISTAMINE / COUGH SUPPRESSANT

PHENYLEPHRINE HCI /

NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Relieves aches, fever, sore throat, nasal congestion, runny nose, & sneezing 
  • Controls cough
  • For ages 12 & over

DAYTIME

Severe Congestion & Cough

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCI / NASAL DECONGESTANT

MAXIMUM STRENGTH

  • Controls Cough
  • Clears nasal & chest congestion
  • Thins & loosens mucus
  • For ages 12 & over

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® FAST-MAX® Severe Congestion & Cough & Nighttime Cold & Flu.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WALGREENS Daytime Severe Congestion & Cough Nighttime Cold & Flu
WALGREENS Daytime Severe Congestion & Cough Nighttime Cold & Flu

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917177762GTIN-13: 0311917177762
EAN-13: 0311917177762
GTIN-12: 311917177762
UPC-A: 311917177762
GTIN storage (14 digits): 00311917177762		mucus-relief-congestion-and-cough-max-strength-and-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0862-12ML - Milliliter0363-0862797e8220-a778-4557-ba86-8b7de73d147b12022-06-06
0363-0337-06ML - Milliliter0363-033710187a7e-ec2e-4648-8c35-99415687a2e412015-07-20
0363-0337-09ML - Milliliter0363-033788c223e3-26e1-4511-bd4d-2d5fd0efc55412022-06-06
0363-0460-06ML - Milliliter0363-04607b2a4e71-1b15-4bbc-8262-c63652fc805e12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-08620363-0862-12
0363-03370363-0337-06
0363-04600363-0460-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYL GALLATE8D4SNN7V92IACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-07-16full-release2026-06-01 00:15:21

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
ndc (package): 0363-0862-12
ndc (package): 0363-0460-06
ndc (package): 0363-0337-06
ndc (product): 0363-0862
ndc11 (package): 00363033706
ndc11 (package): 00363046006
ndc11 (package): 00363086212
spl id: 9fdde4b1-1674-4cd6-ac32-2279467eb162
spl set id: 366ddac8-9e8a-41bd-a7f7-48213485a5f8
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
ndc (package): 0363-0460-06
ndc (product): 0363-0460
ndc11 (package): 00363046006
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
ndc (package): 0363-0337-06
ndc (product): 0363-0337
ndc11 (package): 00363033706

Reported adverse events (FAERS/openFDA)#

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