MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride 
RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug Facts

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

Active ingredients (in each 20 mL)
Mucinex Fast-Max Severe Congestion & Cough
Purposes
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant
Active ingredients (in each 20 mL)
Mucinex Nightshift Cold & Flu
Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Triprolidine HCl 2.5 mgAntihistamine

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 irritants
    • the intensity of coughing
    • nasal congestion due to a cold
    • the impulse to cough to help you get to sleep

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

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:

  • skin reddening
  • blisters
  • rash

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

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)

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 (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 1, xanthan gum


1
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.

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

PRINCIPAL DISPLAY PANEL - Kit Carton

DAY & NIGHT
COUGH & COLD RELIEF

MAXIMUM STRENGTH
NDC 63824-117-66

Mucinex®
FAST-MAX ®

SEVERE CONGESTION
& COUGH

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

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 FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-117
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-117-661 in 1 CARTON06/30/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 180 mL
Part 21 BOTTLE 180 mL
Part 1 of 2
MUCINEX NIGHTSHIFT   COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-503
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-503-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2019
Part 2 of 2
MUCINEX FAST-MAX   SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-540
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-540-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/24/2019
Labeler - RB Health (US) LLC (081049410)

Revised: 6/2023
Document Id: fda3bd7d-76b0-ca9b-e053-6394a90a4ec9
Set id: 4592d547-556f-4eec-8faf-6ff9a92e46c8
Version: 3
Effective Time: 20230608
 
RB Health (US) LLC