Label: MUCINEX FAST-MAX COLD, FLU AND SORE THROAT AND MUCINEX NIGHTSHIFT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
- NDC Code(s): 63824-015-66, 63824-119-66, 63824-503-66
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients (in each 20 mL)
Mucinex Fast-Max Cold, Flu & Sore ThroatPurposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant Active ingredients (in each 20 mL)
Mucinex Nightshift Cold & FluPurposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine -
Uses
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
- temporarily relieves these common cold and flu symptoms:
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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
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.
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Directions
MUCINEX FAST-MAX COLD, FLU & SORE THROAT
- 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
- 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 Fast-Max Cold, Flu & Sore Throat)
- Inactive ingredients (Mucinex Nightshift Cold & Flu)
- Questions?
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PRINCIPAL DISPLAY PANEL - Kit Carton
DAY & NIGHT
COLD & FLU RELIEFMAXIMUM STRENGTH
NDC 63824-119-66
Mucinex®
FAST-MAX ®COLD, FLU
& SORE THROATAcetaminophen–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®
NIGHTSHIFTCOLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – AntihistamineNIGHTTIME
RELIEF FOR A BETTER
MORNING✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZINGFOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)FOR
AGES 12+ -
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD, FLU AND SORE THROAT AND MUCINEX NIGHTSHIFT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-119 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-119-66 1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 06/30/2022 04/01/2025 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 MUCINEX NIGHTSHIFT COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solutionProduct Information 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 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:63824-503-66 180 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 06/15/2019 Part 2 of 2 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information 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 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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:63824-015-66 180 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 02/07/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/17/2019 04/01/2025 Labeler - RB Health (US) LLC (081049410)