Label: 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
- NDC Code(s): 63824-116-66, 63824-267-66, 63824-270-66
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 24, 2023
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- Official Label (Printer Friendly)
- Drug Facts
-
ACTIVE INGREDIENT
Mucinex Sinus-Max
SEVERE CONGESTION & PAIN CLEAR & COOL
Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestantMucinex 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 productiveMucinex 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
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
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 - OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
(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 - QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
-
PURPOSE
Acetaminophen 650mg.......... ................Pain reliever
Guaifenesin 400 mg.................................Expectorant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestantAcetaminophen 650mg..........Pain reliever/fever reducer
Dextromethorphan HBr 20 mg..............Cough suppressant
Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
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 kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-116 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-116-66 1 in 1 CARTON 01/01/2019 01/29/2024 1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 180 mL Part 2 1 BOTTLE 180 mL Part 1 of 2 MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL
acetaminophen, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC:63824-267 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color green Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-267-66 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2019 Part 2 of 2 MUCINEX NIGHTSHIFT SINUS CLEAR AND COOL
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solutionProduct Information Item Code (Source) NDC:63824-270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 20 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL Inactive Ingredients Ingredient Name Strength 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 Color green Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-270-66 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2019 01/29/2024 Labeler - RB Health (US) LLC (081049410)