FDA Label for Mucinex Nightshift Cold And Flu

Other

Drug Facts

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

Otc - Purpose

Mucinex Fast-Max Cold, Flu & Sore Throat

• 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
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • 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

• temporarily relieves these common cold and flu symptoms:
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • 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
  • 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
  
  

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.

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 & Sore Throat only)
• diabetes (Fast-Max Cold, Flu & Sore Throat only)
• high blood pressure (Fast-Max Cold, Flu & Sore Throat only)
• thyroid disease (Fast-Max Cold, Flu & Sore Throat 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 & Sore Throat only)
• pain, nasal congestion, or cough gets worse or lasts more than 7 days (Fast-Max Cold, Flu & Sore Throat 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

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

Otc - Keep Out Of Reach Of Children

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.

Other Information

• each 20 mL contains: sodium 12 mg (Fast-Max Cold, Flu & Sore Throat 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 & Sore Throat)

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

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.

Principal Display Panel - Kit Carton

DAY & NIGHT
COLD & FLU RELIEF

MAXIMUM STRENGTH

NDC 63824-119-66

Mucinex®
FAST-MAX^®

COLD, FLU
& SORE THROAT

Acetaminophen–Pain Reliever/Fever Reducer
Dextromethorphan HBr–Cough Suppressant
Guaifenesin–Expectorant
Phenylephrine HCl–Nasal Decongestant

• ✔Controls Cough, Thins & Loosens Mucus
• ✔Nasal & Chest Congestion
• ✔Sinus Pressure & Congestion
• ✔Body Pain, Headache, Fever & Sore Throat

Mucinex®
NIGHTSHIFT

COLD & FLU

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

NIGHTTIME
RELIEF FOR A BETTER
MORNING

✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING

FOR
AGES 12+


TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)

FOR
AGES 12+

Principal Display Panel - Kit Carton - mucinex 01