Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu

Reckitt Benckiser LLC

Mucinex® Fast-Max Day Time Severe Congestion and Cough and Mucinex® Fast-Max Night Time Cold and Flu Maximum Strength

FULL PRESCRIBING INFORMATION: CONTENTS*

• Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Uses
• Warnings
  • Liver warning (Night Time only)
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • Overdose warning (Night Time only)
• Directions
• Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Other information
• Inactive ingredients (Day Time)
• Inactive ingredients (Night Time)
• Questions?
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Uses

• temporarily relieves (Day Time only) :
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Day Time only)
• temporarily relieves these common cold and flu symptoms (Night Time only)
  • nasal congestion
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • runny nose and sneezing
• temporarily reduces fever (Night Time only)
• controls cough to help you get to sleep

Warnings

Liver warning (Night Time only)

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

• more than 6 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warning (Night Time only): 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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Night Time only)
• with any other drug containing diphenhydramine, even one used on the skin (Night Time 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.
• for children under 12 years of age

Ask a doctor before use if you have

• liver disease (Night Time only)
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma (Night Time only)
• a breathing problem such as emphysema or chronic bronchitis (Night Time 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

• taking the blood thinning drug warfarin (Night Time only)
• taking sedatives or tranquilizers (Night Time only)

When using this product do not use more than directed.

In addition, for Night Time only:

• 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

• nervousness, dizziness or sleeplessness occur
• symptoms do not get better within 7 days or occur with fever (Day Time only)
• pain, nasal congestion, or cough gets worse, or lasts more than 7 days (Night Time only)
• fever gets worse, or lasts more than 3 days (Night Time only)
• redness or swelling is present (Night Time only)
• new symptoms occur (Night Time only)
• 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, ask a health professional before use.

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

Overdose warning (Night Time only)

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

• 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
• mL = milliliter
• adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
• children under 12 years of age: do not use

Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Other information

• each 20 mL contains: sodium 14 mg (DAY TIME only) and sodium 12 mg (NIGHT TIME only)
• do not refrigerate
• store between 20-25°C (68-77°F)
• dosing cup provided

Inactive ingredients (Day Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay contain this ingredient, xanthan gum

Inactive ingredients (Night Time)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydratemay contain this ingredient, xanthan gum

Questions?

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

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 63824-528-22

MAXIMUM STRENGTH*

Mucinex®
FAST-MAX ^®

DAY TIME
Severe Congestion
& Cough

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

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

Mucinex®
FAST-MAX ^®

NIGHT TIME
Cold & Flu

Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine/Cough Suppressant
Phenylephrine HCl • Nasal Decongestant

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

*per 4 hour dose.

AGE 12+ TWO – 6 fl oz (180 mL) bottles TOTAL – 12 fl oz (360 mL) AGE 12+