Mucinex® Fast-Max ® Severe Congestion & Cough and Mucinex® Nightshift Cold & Flu

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg..............Cough suppressant Guaifenesin 400 mg.................................Expectorant Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Acetaminophen 650mg..........Pain reliever/fever reducer Dextromethorphan HBr 20 mg..............Cough suppressant Phenylephrine HCl 10 mg. . . . . . . . . . . . . . . . . Nasal decongestant Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . . Antihistamine

OTC - PURPOSE SECTION

Uses

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool ■ 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 ■ 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

MUCINEX FAST-MAX SEVERE CONGESTION & COUGH

• 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 irritantsthe intensity of coughingnasal congestion due to a coldthe impulse to cough to help you get to sleep

MUCINEX NIGHTSHIFT COLD & FLU

• temporarily relieves these common cold and flu symptoms: coughminor aches and painssore throatheadacherunny nosesneezingitching of the nose or throatitchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep

RECENT MAJOR CHANGES SECTION

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool ■ 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 ■ 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

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

Liver warning (Nightshift Cold & Flu only)

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 only)

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

Sore throat warning (Nightshift Cold & Flu 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. (Nightshift Cold & Flu 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

• liver disease (Nightshift Cold & Flu only)
• heart disease (Fast-Max Severe Congestion & Cough only)
• high blood pressure (Fast-Max Severe Congestion & Cough only)
• thyroid disease (Fast-Max Severe Congestion & Cough only)
• diabetes (Fast-Max Severe Congestion & Cough only)
• glaucoma (Nightshift Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu 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 (Nightshift Cold & Flu only)
• taking sedatives or tranquilizers (Nightshift Cold & Flu only)

When using this product

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

Stop use and ask a doctor if

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

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 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

Mucinex Fast-Max Severe Congestion & Cough Clear & Cool ■ 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 ■ 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

MUCINEX FAST-MAX SEVERE CONGESTION & COUGH

• 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

• 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

■ 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 (Mucinex Fast-Max Severe Congestion & Cough)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient, xanthan gum

Inactive ingredients (Mucinex Nightshift Cold & Flu)

ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

Questions?

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