Label: MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN AND MUCINEX NIGHTSHIFT SINUS- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
- NDC Code(s): 63824-115-66, 63824-266-66, 63824-269-66
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
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Uses
Mucinex Sinus-Max Severe Congestion & Pain
- 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
- 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
- temporarily relieves:
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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 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
- high blood pressure
- thyroid disease
- diabetes
- glaucoma (Nightshift Sinus only)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nightshift Sinus 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 only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Nightshift Sinus only)
- marked drowsiness may occur (Nightshift Sinus only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Sinus only)
- avoid alcoholic drinks (Nightshift Sinus only)
- use caution when driving a motor vehicle or operating machinery (Nightshift Sinus 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.
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Directions
Mucinex Sinus-Max Severe Congestion & Pain
- 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
- 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
- Inactive ingredients (Mucinex Sinus-Max Severe Congestion & Pain)
- Inactive ingredients (Mucinex Nightshift Sinus)
- Questions?
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PRINCIPAL DISPLAY PANEL - Kit Carton
DAY & NIGHT
SINUS CONGESTION & PAIN RELIEFMAXIMUM STRENGTH*
NDC 63824-115-66
Mucinex®
SINUS-MAX®SEVERE CONGESTION
& PAINAcetaminophen – Pain Reliever
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant- Clears Sinus Congestion
- Relieves Headache
- Thins & Loosens Mucus
FOR
AGES 12+Mucinex®
NIGHTSHIFTSINUS
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – AntihistamineNIGHTTIME
RELIEF FOR A BETTER
MORNING✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTIONFOR
AGES 12+TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL) -
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN AND MUCINEX NIGHTSHIFT SINUS
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-115 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-115-66 1 in 1 CARTON 05/30/2022 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
acetaminophen, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC:63824-266 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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 Color blue Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-266-66 180 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 Drug M012 05/30/2022 Part 2 of 2 MUCINEX NIGHTSHIFT SINUS
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solutionProduct Information Item Code (Source) NDC:63824-269 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 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 Inactive Ingredients Ingredient Name Strength 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 Color blue Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-269-66 180 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 Drug M012 05/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/30/2022 Labeler - RB Health (US) LLC (081049410)