MUCINEX-SINUS MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL AND MUCINEX NIGHTSHIFT SINUS CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, 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 Sinus-Max Severe Congestion & Pain Clear & Cool and Mucinex Nightshift Sinus Clear & Cool

Drug Facts

Mucinex Sinus-Max
SEVERE CONGESTION & PAIN CLEAR & COOL
Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

Mucinex Nightshift
Sinus Clear & Cool
Acetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine

Uses

Mucinex Sinus-Max SEVERE CONGESTION & PAIN
CLEAR & COOL
temporarily relieves:
■ nasal congestion

■ headache

■ minor aches and pains
■ sinus congestion and pressure
■ 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

Mucinex Nightshift Sinus 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: 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 (Nightshift Sinus 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.

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 ■ diabetes
■ high blood pressure
■ thyroid disease
■ glaucoma (Nightshift Sinus Clear & Cool only)
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
(Nightshift Sinus Clear & Cool 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 Sinus Clear & Cool only)

When using this product ■ do not use more than directed
■ excitability may occur, especially in children (Nightshift Sinus
Clear & Cool only)
■ marked drowsiness may occur (Nightshift Sinus Clear & Cool
only)
■ alcohol, sedatives, and tranquilizers may increase drowsiness
(Nightshift Sinus Clear & Cool only)
■ avoid alcoholic drinks (Nightshift Sinus Clear & Cool only)
■ use caution when driving a motor vehicle or operating machinery
(Nightshift Sinus Clear & Cool only)

Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion, or cough gets worse or lasts more than
7 days
■ 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.

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


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 SINUS-MAX SEVERE CONGESTION & PAIN
CLEAR & COOL

■ 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 SINUS 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

■ each 20 mL contains: sodium
9mg (Severe Congestion & Pain
Clear & Cool only) and sodium
16mg (Nightshift Sinus Clear &
Cool only)
■ store at 20-25°C (68-77°F)
■ do not refrigerate

(Mucinex Sinus-Max
Severe Congestion & Pain
Clear & Cool)

anhydrous citric
acid, D&C yellow no. 10, edetate
disodium, FD&C blue no. 1,
flavors, glycerin, propyl gallate,
propylene glycol, purified water,
sodium benzoate, sorbitol,
sucralose, trisodium citrate
dihydrate*, xanthan gum
*may contain this ingredient

(Mucinex Nightshift
Sinus Clear & Cool)

ammonium glycyrrhizate,
anhydrous citric acid, D&C
yellow no. 10, edetate disodium,
FD&C blue no. 1, flavors,
glycerin (soy), propylene glycol,
sodium benzoate, sorbitol,
sucralose, water, xanthan gum

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

Keep out of reach of children

Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

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

LabelLabelLabel

MUCINEX-SINUS MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL AND MUCINEX NIGHTSHIFT SINUS CLEAR AND COOL 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-116
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-116-661 in 1 CARTON01/01/201901/29/2024
11 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 180 mL
Part 21 BOTTLE 180 mL
Part 1 of 2
MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL 
acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-267
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-267-66180 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 finalpart34101/01/2019
Part 2 of 2
MUCINEX NIGHTSHIFT   SINUS CLEAR AND COOL
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
Product Information
Item Code (Source)NDC:63824-270
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-270-66180 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 finalpart34101/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/201901/29/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 8/2023
 
RB Health (US) LLC