Maximum Strength Mucinex® Fast-Max ® Cold & Flu and Mucinex® NightShift Severe Cold & Flu

RB Health (US) LLC

Dosage Form

N/A

Manufacturer

RB Health (US) LLC

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

NDC 72854-154-26

DAY & NIGHT COLD & FLU PACK

Mucinex®

FAST-MAX ^®

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant

SORE THROAT

FEVER

HEADACHE

BODY PAIN

ALL IN

ONE*

CHEST CONGESTION

COUGH

NASAL CONGESTION

SINUS CONGESTION

SINUS PRESSURE

FOR

AGES 12+

TWO – 6 FL OZ (180 mL) bottles

MAXIMUM STRENGTH

Mucinex®

NIGHTTIME

COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant • Triprolidine HCl – Antihistamine

SORE THROAT

FEVER

HEADACHE

BODY PAIN

ALL IN

ONE*

ITCHY THROAT

COUGH

NASAL CONGESTION

SNEEZING

RUNNY NOSE

TOTAL – 12 FL OZ (360 mL)

FOR

AGES 12+

[image: img_3ba3c518-2372-e4b1-e063-6394a90a2420]

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What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

63824-504-66
63824-548-66
72854-154-26

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

MUCINEX FAST-MAX COLD & FLU

temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- stuffy nose
- sinus congestion and pressure
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

MUCINEX NIGHTSHIFT SEVERE COLD & FLU

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

Liver warning

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

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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

MUCINEX FAST-MAX COLD & FLU

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 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 SEVERE COLD & FLU

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

SPL UNCLASSIFIED SECTION

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

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Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.

Do not use if…Keep out of reach of children.

Ask a doctor before use if…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 come…

Ask a doctor or pharmacist before use if…taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nightshift Severe Cold & Flu only)

Stop use and talk to a doctor if…with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidas…

Storage and handlingeach 20 mL contains: sodium 12 mg (Fast-Max Cold & Flu only) and sodium 16 mg (Nightshift Severe Cold & Flu only) store at 20-25°C (68-77°F) do not refrigerate

Package labelNDC 72854-154-26 DAY & NIGHT COLD & FLU PACK Mucinex® FAST-MAX ® COLD & FLU Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decon…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

MUCINEX FAST-MAX COLD & FLU

MUCINEX NIGHTSHIFT SEVERE COLD & FLU

Liver warning

Allergy alert

Sore throat warning

Overdose warning

MUCINEX FAST-MAX COLD & FLU

MUCINEX NIGHTSHIFT SEVERE COLD & FLU

SPL UNCLASSIFIED SECTION

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