Label: MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU AND MUCINEX FAST-MAX RECHARGE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, and triprolidine hcl kit
- NDC Code(s): 72854-138-66, 72854-167-66, 72854-188-26
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 11, 2026
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
PURPOSE
Day:
Acetaminophen 650mg.................................Pain reliever/fever reducer
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg..............................................................................Expectorant
Phenylephrine HCl 10 mg..........................................................Nasal decongestantNight:
Acetaminophen 650 mg............................ ...Pain reliever/fever reducer
Dextromethorphan HBr 20 mg....................................Cough suppressant
Triprolidine HCl 2.5 mg................................................Antihistamine -
INDICATIONS & USAGE
Uses
Day:■ 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
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial
passageways of bothersome mucus and make coughs more productiveNight:
■ 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
Warnings:
Day:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 6 doses 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 ■ diabetes ■ high blood pressure
■ thyroid disease ■ trouble urinating due to an enlarged prostate gland
■ 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
warfarinWhen using this product do not use more than directed
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.Night:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 4 doses (80 mL) in 24 hours, which is the maximum daily amount for this
product
■ 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 ■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ persistent or chronic cough such as occurs with smoking, asthma, 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
When using this product ■ do not use more than directed
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
■ pain 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 rash or
headache that lasts. These could be signs
of a serious condition. -
DOSAGE & ADMINISTRATION
Directions
Day:
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 useNight:
■ 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
-
KEEP OUT OF REACH OF CHILDREN
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. -
INACTIVE INGREDIENT
Inactive ingredients
Day:
ammonium glycyrrhizate, anhydrous citric acid, D&C yellow no.
10, edetate disodium, FD&C blue no. 1, flavors,
glycerin, propylene glycol, purified water, sodium
benzoate, sodium citrate, sorbitol, sucralose,
xanthan gumNight:
ammonium glycyrrhizate, anhydrous citric acid, D&C
yellow no. 10, edetate disodium, FD&C red no.
40, flavor, glycerin (soy), propylene glycol,
purified water, sodium benzoate, sorbitol
solution, sucralose, xanthan gum - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU AND MUCINEX FAST-MAX RECHARGE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, and triprolidine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-188 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-188-26 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 07/01/2026 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE 1 mL Part 2 0 BOTTLE 1 mL Part 1 of 2 MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Item Code (Source) NDC:72854-138 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 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 Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) XANTHAN GUM (UNII: TTV12P4NEE) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:72854-138-66 180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/01/2026 Part 2 of 2 MUCINEX FAST-MAX RECHARGE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, triprolidine hydrochloride solutionProduct Information Item Code (Source) NDC:72854-167 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 TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color orange Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-167-66 180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/01/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/01/2026 Labeler - RB Health (US) LLC (081049410)


