Nighttime Cold and Flu

Manufacturer
TARGET Corporation
Effective date
2023-11-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:30

Label at a glance#

ProductNighttime Cold and Flu Maximum Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 keep dosing cup with product  mL = milliliter 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCI 25 mg 

Phenylephrine HCI 10 mg 

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Antihistamine / cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning:

This product contains 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

  • with any other 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 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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 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

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
  • keep dosing cup with product 
  • mL = milliliter
  • 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

 Call 1-800-910-6874

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

maximum strength

Nighttime

cold and Flu

acetaminophen

( pain reliever / fever reducer)

diphenhydramine HCI

(antihistamine / cough suppressant)

phenylephrine HCI

(nasal decongestant)

relieves aches, fever and sore throat

controls cough

relieves nasal congestion

relieves runny nose & sneezing

AGES 12 + YEARS

FL OZ (mL)

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

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

Dist. by Target Corp.

Mpls., MN 55403

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TARGET Maximum Strength Nigh Time Cold and Flu
TARGET Maximum Strength Nigh Time Cold and Flu

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-460NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) LIQUID [TARGET CORPORATION]4Legacy NDC20231103_39abb612-7f28-485f-bb14-475b28834d3e.zip

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-46011673-460-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6415d4e-7448-4a79-ba0f-af7aa244adfa39abb612-7f28-485f-bb14-475b28834d3e2023-11-02WarningsExact identifier
spl id: b6415d4e-7448-4a79-ba0f-af7aa244adfa
spl set id: 39abb612-7f28-485f-bb14-475b28834d3e

Reported adverse events (FAERS/openFDA)#

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