Fast Maximum Night Time Cold and Flu

Manufacturer
7-Eleven | Aurohealth LLC
Effective date
2020-11-26
Label type
Human OTC Drug Label
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:03:59

Label at a glance#

ProductFast Maximum Night 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 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) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter; tsp = teaspoon adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours children under 12 years of age: do not use unless directed by a doctor

Storage and handling

Each 20 mL contains: sodium 12 mg tamper evident: do not use if printed seal under cap is torn or missing Store at 20-25°C (68-77°F) do not refrigerate dosing cup provided

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL(4 tsp) dose)

Acetaminophen USP 650 mg
Diphenhydramine HCl USP 25 mg
Phenylephrine HCl USP 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
    • 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 daily 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
  • if you have ever had an allergic reaction to this product or any of its ingredients Avoid foods or beverages that contain caffeine

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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
  • 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 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) may cause liver damage. 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)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter; tsp = teaspoon
  • adults and children 12 years of age and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
  • children under 12 years of age: do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Each 20 mL contains: sodium 12 mg
  • tamper evident: do not use if printed seal under cap is torn or missing
  • Store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue, FD&C red, flavors, glycerin, noncrystallizing sorbitol solution, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Questions or Comments

OTC - QUESTIONS SECTION

1-855-274-4122

You may also report side effects to this phone number.


*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® FAST-MAX® NIGHTTIME COLD & FLU

**per 4 hour dose
Dose every 4 hours


DISTRIBUTED BY
7-ELEVEN, INC.
IRVING, TX 75063
WWW.7-ELEVEN.COM

Satisfaction Guaranteed
1-800-255-0711

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24/7 life *
BY 7-ELEVENTM


Maximum Strength**
Fast Maximum
Nighttime Cold & Flu

Acetaminophen USP
(Pain Reliever/Fever Reducer)
Diphenhydramine HCl USP
(Antihistamine/Cough Suppressant)
Phenylephrine HCl USP
(Nasal Decongestant)


  • Relieves Aches, Fever & Sore Th­roat
  • Controls Cough
  • Relieves Nasal Congestion
  • Relieves Runny Nose & Sneezing

Compare to Mucinex®
FAST-MAX® NIGHTTIME COLD & FLU

For Ages 12+  6 FL OZ (180 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (180 mL Bottle)

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10202-94710202-947-18

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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
035404c0-fa9b-4e7e-b476-40aed4fda847e13e5624-dfd1-4694-8bc5-c721b4a512a02020-11-26WarningsExact identifier
spl id: 035404c0-fa9b-4e7e-b476-40aed4fda847
spl set id: e13e5624-dfd1-4694-8bc5-c721b4a512a0

Reported adverse events (FAERS/openFDA)#

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