Label: MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHTTIME COLD AND FLU- dextromethorphan hydrobromide, guaifenesin, acetaminophen,triprolidine hydrochloride kit
- NDC Code(s): 72854-143-66, 72854-159-66, 72854-160-26
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 12, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
■ helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial
passageways of bothersome mucus and
make coughs more productive
■ temporarily relieves:
■ cough due to minor throat and
bronchial irritation as may occur with
the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get
to sleep■ 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
Do not use
■ 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
■ persistent or chronic cough such as occurs
with smoking, asthma, chronic bronchitis, or
emphysema
■ cough that occurs with too much phlegm (mucus)When using this product do not use more
than directed
Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
occurs with fever, rash, or headache that lasts.
These could be signs of a serious condition.Liver warning: This product contains acetaminophen. Severe liver damage may occur if
you take:
■ more than 4,000 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 ■ 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 fever,
rash, or headache that lasts. These
could be signs of a serious condition. -
DOSAGE & ADMINISTRATION
Directions
■ 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 useDirections
■ 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
-
INACTIVE INGREDIENT
Inactive ingredients
ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow
no. 10, edetate disodium, FD&C blue no. 1, flavor,
glycerin (soy), propylene glycol, purified water,
sodium benzoate, sorbitol, sucralose, trisodium
citrate dihydrate*, xanthan gum
*may contain this ingredientInactive ingredients ammonium
glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C blue no. 1, FD&C red no.
40, flavor, glycerin (soy), propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHTTIME COLD AND FLU
dextromethorphan hydrobromide, guaifenesin, acetaminophen,triprolidine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-160 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-160-26 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 04/02/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 BOTTLE 1 mL Part 2 0 BOTTLE 1 Part 1 of 2 MUCINEX FAST-MAX NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, triprolidine hydrochloride solutionProduct Information Item Code (Source) NDC:72854-143 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) FD&C RED NO. 40 (UNII: WZB9127XOA) 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) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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:72854-143-66 180 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 04/02/2025 Part 2 of 2 MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin liquidProduct Information Item Code (Source) NDC:72854-159 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) 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:72854-159-66 180 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/02/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/02/2025 Labeler - RB Health (US) LLC (081049410)


