FDA.reportPublic FDA data

Maximum Strength Daytime Severe and Nighttime Cold and Flu

Manufacturer
TARGET Corporation | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:38

Label at a glance#

ProductMaximum Strength Daytime Severe and Nighttime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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 temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronch...

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

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

Pain reliever / fever reducer 

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

  • temporarily relieves these common cold and flu symptoms
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • 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.

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

  • 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIGHTTIME

Compare to active ingredients in Maximum Strength Mucinex®Fast-Max® Night Time Cold & Flu**

maximum strength

nighttime

Cold & Flu

acetaminophen (pain reliever / fever reducer)

diphenhydramine HCI (antihistamine / cough suppressant)

phenylephrine HCI (nasal decongestant)

Relieves aches, fever, sore throat

controls cough

relieves nasal congestion

relieves runny nose and sneezing  

AGES 12 + YEARS

DAYTIME

Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold*

maximum strength

daytime

Severe Cold

acetaminophen (pain reliever / fever reducer)

dextromethorphan HBr (cough suppressant)

guaifenesin (expectorant)

phenylephrine HCI (nasal decongestant)

Relieves aches, fever & sore throat

Controls Cough

relieves nasal and chest congestion 

thins and loosens mucus 

AGES 12 + YEARS

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

*This prodect is not manufactured or distributed by Recitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold.

**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Night Time Cold & Flu.

Dist. by Target Corp.

Minneapolis, MN 55403

Product of U.S.A.

©2016 Target Brands, Inc.

Questions? Call 1-800-910-6874

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg Acetaminophen 650 mg, Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg
Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg Acetaminophen 650 mg, Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1424850{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK1
14248501 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) PackPSN1
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN1
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN1
1116572acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
14248501 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) PackSY1
1116572acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY1
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY1
1116572acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY1
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1116572APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY1
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY1
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY1
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-339-012025-01-30C16284748780-12cef2736-aa6f-d83d-e063-dadaa90ab31f748L Maximum Strength Daytime Severe Nighttime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-339-01Maximum Strength Daytime Severe and Nighttime Cold and Flu1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-339MAXIMUM STRENGTH DAYTIME SEVERE AND NIGHTTIME COLD AND FLU (DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) KIT [TARGET CORPORATION]11 package rows20240501_08ee82b1-74dc-3cdd-e063-6294a90a1eac.zip

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
11673-33911673-339-01
11673-901
11673-320

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB
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
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
08ee83fb-8d98-1768-e063-6394a90aed5b08ee82b1-74dc-3cdd-e063-6294a90a1eac2023-10-30WarningsExact identifier
spl id: 08ee83fb-8d98-1768-e063-6394a90aed5b
spl set id: 08ee82b1-74dc-3cdd-e063-6294a90a1eac

Reported adverse events (FAERS/openFDA)#

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