night time cold and flu

Manufacturer
Kroger Company
Effective date
2020-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:36:54

Label at a glance#

Productnight time cold and flu
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

• temporarily relieves these common cold and flu symptoms: • cough • nasal congestion • minor aches and pains • sinus congestion and pressure • 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 5 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • 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

Storage and handling

• each 20 mL contains: sodium 7 mg • store at 20-25 ° C (68-77 ° F) • dosing cup provided • do not refrigerate

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

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 aches and pains
  • sinus congestion and pressure
  • 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 product containing diphenhydramine, even one used on 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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, 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

  • taking the blood thinning drug warfarin
  • 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 5 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • 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

  • each 20 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triethyl citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredients of MUCINEX® FAST-MAX® NIGHT TIME COLD & FLU

See back panel

for ages 12+

OUR PHARMACIST RECOMMENDED

Maximum Strength

FAST NIGHTTIME

Cold & Flu

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

1 FOR ALL RELIEF

NASAL CONGESTION

SNEEZING, RUNNY NOSE

ACHES, HEADACHE

COUGH, ITCHY THROAT

6 FL OZ (180 mL)

Fast Nighttime Cold & Flu Image 1
Fast Nighttime Cold & Flu Image 1
Fast Nighttime Cold & Flu Image 2
Fast Nighttime Cold & Flu Image 2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-94930142-949-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80c72bcf-2f37-4783-aa11-1de39d07ce1b30663e89-df52-4607-b77e-6bbf3934330c2024-11-11WarningsExact identifier
spl set id: 30663e89-df52-4607-b77e-6bbf3934330c

Reported adverse events (FAERS/openFDA)#

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