Mucinex Fast-Max Nightshift Cold and Flu Clear and Cool

Manufacturer
RB Health (US) LLC
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:44:33

Label at a glance#

ProductMucinex Fast-Max Severe Congestion and Cough Clear and Cool and Maximum Strength Mucinex Nightshift Cold and Flu Clea...
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE, GUAIFENESIN
Label structure11 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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 nasal congestion due to a cold temporarily helps you cough less temporarily relieves these common cold and flu symptoms:...

Dosage and administration

do not take more than 6 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 over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period mea...

Storage and handling

each 20 mL contains: sodium 9 mg (Fast-Max Severe Congestion & Cough Clear & Cool only) and sodium 16 mg (Nightshift Cold & Flu Clear & Cool only) store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Mucinex Fast-Max
Severe Congestion & Cough Clear & Cool
Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10mgNasal decongestant

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)
Mucinex Nightshift
Cold & Flu Clear & Cool
Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCl 10 mgNasal decongestant
Triprolidine HCl 2.5 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool

SPL UNCLASSIFIED SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways 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
    • nasal congestion due to a cold
    • temporarily helps you cough less

Mucinex Nightshift Cold & Flu Clear & Cool

SPL UNCLASSIFIED SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sinus congestion and pressure
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily reduces fever
  • controls cough to help you get to sleep

Warnings

WARNINGS SECTION

Liver warning (Nightshift Cold & Flu Clear & Cool only)

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 mg in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert (Nightshift Cold & Flu Clear & Cool only)

SPL UNCLASSIFIED SECTION

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 (Nightshift Cold & Flu Clear & Cool only)

SPL UNCLASSIFIED SECTION

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. (Nightshift Cold & Flu Clear & Cool only)
  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease (Nightshift Cold & Flu Clear & Cool only)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma (Nightshift Cold & Flu Clear & Cool only)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu Clear & Cool only)
  • 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

  • taking the blood thinning drug warfarin (Nightshift Cold & Flu Clear & Cool only)
  • taking sedatives or tranquilizers (Nightshift Cold & Flu Clear & Cool only)

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children (Nightshift Cold & Flu Clear & Cool only)
  • marked drowsiness may occur (Nightshift Cold & Flu Clear & Cool only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu Clear & Cool only)
  • avoid alcoholic drinks (Nightshift Cold & Flu Clear & Cool only)
  • use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu Clear & Cool only)

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 (Nightshift Cold & Flu Clear & Cool only)
  • fever gets worse or lasts more than 3 days (Nightshift Cold & Flu Clear & Cool only)
  • redness or swelling is present (Nightshift Cold & Flu Clear & Cool only)
  • new symptoms occur (Nightshift Cold & Flu Clear & Cool only)
  • symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough Clear & Cool only)
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Overdose warning (Nightshift Cold & Flu Clear & Cool only)

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool

SPL UNCLASSIFIED SECTION

  • do not take more than 6 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 over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Mucinex Nightshift Cold & Flu Clear & Cool

SPL UNCLASSIFIED SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 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 over: 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 9 mg (Fast-Max Severe Congestion & Cough Clear & Cool only) and sodium 16 mg (Nightshift Cold & Flu Clear & Cool only)
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

(Mucinex Fast-Max Severe Congestion & Cough Clear & Cool)

SPL UNCLASSIFIED SECTION

anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

(Mucinex Nightshift Cold & Flu Clear & Cool)

SPL UNCLASSIFIED SECTION

ammonium glycyrrhizate, anhydrous citric acid, D&C yellow no. 10, edetate disodium, FD&C blue no. 1, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, water, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX
(1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NDC 63824-136-66

Mucinex®
FAST-MAX®

SEVERE CONGESTION
& COUGH

CLEAR & COOL ®

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thins & Loosens Mucus

FOR
AGES 12+

TWO – 6 FL OZ (180 mL) bottles

Mucinex®
NIGHTSHIFT

COLD & FLU
CLEAR & COOL

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✔ COUGH ✔ FEVER ✔ SORE THROAT
✔ RUNNY NOSE ✔ SNEEZING ✔ NASAL CONGESTION

TOTAL – 12 FL OZ (360 mL)

FOR
AGES 12+

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-136-66ML - Milliliter63824-136d810b7e3-ff50-4078-b85f-5b3f7102229612023-01-09

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
63824-13663824-136-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
0a3a057d-0bb6-e13a-e063-6294a90a8bddd95e0e90-b767-496d-bb7c-e4a750a41c392023-11-15WarningsExact identifier
spl set id: d95e0e90-b767-496d-bb7c-e4a750a41c39

Reported adverse events (FAERS/openFDA)#

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