MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHTTIME COLD AND FLU- dextromethorphan hydrobromide, guaifenesin, acetaminophen,triprolidine hydrochloride kit

Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg

PURPOSE

Dextromethorphan HBr » Cough Suppressant
Guaifenesin » Expectorant

Acetaminophen » Pain reliever/fever reducer
Dextromethorphan » Cough suppressant
Triprolidine HCl » Antihistamine

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 use

Directions
■ 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

Other information
■ each 20 mL contains: sodium 9 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

Other information
■ each 20 mL contains: sodium 16 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

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 ingredient

Inactive 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

Questions?
1-866-MUCINEX (1-866-682-4639)

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 kit

Product 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 solution

Product 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 liquid

Product 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)