MUCINEX FAST-MAX LIQUID GELS DAY NIGHT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit

MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu by

Drug Labeling and Warnings

MUCINEX FAST-MAX Liquid Gels Day Night 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

PURPOSE

Purpose Day:
Acetaminophen 325 mg...Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.......Cough suppressant

Purpose Night:

Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg.......Cough suppressant
Doxylamine succinate 6.25 mg............. Antihistamine

ACTIVE INGREDIENT

Day:

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Night:

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

INDICATIONS & USAGE

Day:

■ temporarily relieves these common cold and flu
symptoms:
■ 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
■ minor aches and pains ■ sore throat
■ headache
■ temporarily reduces fever

Night:

■ 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

Day:

Liver warning: This product contains
acetaminophen. Severe liver damage may occur if
you take:
■ more than 12 capsules 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
■ 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

When using this product do not use more than
directed

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.

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.

Night:

Severe liver damage may occur if you take:
■ more than 12 capsules 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

DOSAGE & ADMINISTRATION

Day:

Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules every 4 hours
■ children under 12 years of age: do not use

Night:

Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 capsules in any 24-hour
period
■ adults and children 12 years of age and over: take 2
capsules every 4 hours
■ children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information
■ store at 20-25°C (68-77°F)
■ avoid excessive heat

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

Day:

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide

Night:

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,
hypromellose, isopropyl alcohol, lecithin (sunflower),
light mineral oil, mannitol, polyethylene glycol 400,
povidone, propylene glycol, purified water, 1,4-sorbitan,
sorbitol, titanium dioxide

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX LIQUID GELS DAY NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-168

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-168-10	1 in 1 CARTON	06/01/2025
1		1 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 72854-168-24	2 in 1 CARTON	06/01/2025
2		1 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BLISTER PACK	1
Part 2	0 BLISTER PACK	1

Part 1 of 2

MUCINEX FAST-MAX COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Item Code (Source)	NDC: 72854-171
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
1,4-SORBITAN (UNII: AV0YTZ4E6J)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code	AR18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-171-08	1 in 1 CARTON
1		8 in 1 BLISTER PACK; 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	06/01/2025

Part 2 of 2

MUCINEX FAST-MAX NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 72854-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SORBITOL (UNII: 506T60A25R)
1,4-SORBITAN (UNII: AV0YTZ4E6J)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	24mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		4 in 1 BLISTER PACK; 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/01/2025

Labeler - RB Health (US) LLC (081049410)