Mucinex® Fast-Max ®Cold & Flu and Mucinex® NightShift Cold & Flu

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

MUCINEX FAST-MAX COLD & FLU

• temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus 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 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

Warnings

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:

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

• skin reddening
• blisters
• rash

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

• 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 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
• heart disease (Fast-Max Cold & Flu only)
• diabetes (Fast-Max Cold & Flu only)
• high blood pressure (Fast-Max Cold & Flu only)
• thyroid disease (Fast-Max Cold & Flu 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
• 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

• nervousness, dizziness, or sleeplessness occur (Fast-Max Cold & Flu only)
• pain, nasal congestion, or cough gets worse or lasts more than 7 days (Fast-Max Cold & Flu only)
• pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only)
• 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.

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.

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.

Directions

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 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 12 mg (Fast-Max Cold & Flu only)and sodium 16 mg (Nightshift Cold & Flu only)
• store at 20-25°C (68-77°F)
• do not refrigerate

Inactive ingredients (MUCINEX FAST-MAX COLD & FLU)

anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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