MUCINEX RAPID CLEAR DAY NIGHT AND CLEAR AND COOL NASAL- acetaminophen, guaifenesin, dextromethorphan hydrobromide, triprolidine hydrochloride, and oxymetazoline hydrochloride kit

MUCINEX Rapid Clear Day Night and Clear and Cool Nasal by

Drug Labeling and Warnings

MUCINEX Rapid Clear Day Night and Clear and Cool Nasal 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

DAY

Acetaminophen 325 mg
Guaifenesin 200 mg

NIGHT

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg

SPRAY

Oxymetazoline hydrochloride 0.05%

PURPOSE

DAY

Acetaminophen 325 mg ........ Pain reliever/
fever reducer
Guaifenesin 200 mg.................... Expectorant

NIGHT

Acetaminophen 325 mg ........ Pain reliever/fever reducer
Dextromethorphan HBr 10 mg................Cough suppressant
Triprolidine HCl 1.25 mg...................................Antihistamine

SPRAY

Oxymetazoline hydrochloride 0.05% - Nasal decongestant

INDICATIONS & USAGE

DAY

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ minor aches and pains ■ headache
■ sore throat
■ helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial
passageways of bothersome mucus and make
coughs more productive
■ temporarily reduces fever

NIGHT

Uses
■ 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

SPRAY

Uses

temporarily relieves nasal congestion due to:

• a cold
• hay fever or other upper respiratory allergies
• promotes nasal and sinus drainage
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages; shrinks swollen membranes

WARNINGS

DAY

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

Ask a doctor before use if you have
■ liver disease
■ 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
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.

If pregnant or breast-feeding, ask a health
professional before use.

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

Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 8 caplets 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 amotor vehicle or operatingmachinery
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.

SPRAY

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage
do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
the use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms persist

If pregnant or breast-feeding,ask a health professional before use.

DOSAGE & ADMINISTRATION

DAY

Directions
■ do not take more than directed (see
Overdose warning)
■ do not take more than 12 caplets in any
24-hour period
■ adults and children 12 years of age and
over: take 2 caplets 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 8 caplets in any 24-hour period
■ adults and children 12 years of age and over: take
2 caplets every 4 hours
■ children under 12 years of age: do not use

SPRAY

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
children under 6 years of age: consult a doctor.

Shake well before use.

To open, hold by the white grips then squeeze, push down
firmly and turn cap counterclockwise. Before using for the
first time, remove the protective cap from the tip and prime
metered pump by depressing firmly several times. To spray,
hold bottle with thumb at the base and nozzle between first
and second fingers. Without tilting head, insert nozzle into
nostril. Fully depress pump all the way down with a firm
even stroke and sniff deeply. Wipe nozzle clean after use.
To close, turn cap clockwise.
DO NOT DISCARD CAP.

OTHER SAFETY INFORMATION

DAY/NIGHT/SPRAY

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

INACTIVE INGREDIENT

DAY

Inactive ingredients
croscarmellose sodium, FD&C red no. 40
aluminum lake, FD&C yellow no. 6 aluminum
lake, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, talc, titanium dioxide

NIGHT

Inactive ingredients
croscarmellose sodium, crospovidone, hypromellose,
microcrystalline cellulose, polyethylene glycol,
polysorbate 80, povidone, titanium dioxide

SPRAY

benzalkonium chloride,
benzododecinium chloride,
camphor

QUESTIONS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If pregnant or breast-feeding,ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX RAPID CLEAR DAY NIGHT AND CLEAR AND COOL NASAL 
acetaminophen, guaifenesin, dextromethorphan hydrobromide, triprolidine hydrochloride, and oxymetazoline hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-213

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-213-03	1 in 1 CARTON	06/01/2025
1		1 in 1 KIT; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 BLISTER PACK	8
Part 3	0 BOTTLE, PUMP	1 mL

Part 1 of 3

MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH 
acetaminophen, guaifenesin tablet, film coated

Product Information
Item Code (Source)	NDC: 72854-208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	VVV;MSC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 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	05/01/2025

Part 2 of 3

MUCINEX NIGHTSHIFT SINUS  MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride tablet, coated

Product Information
Item Code (Source)	NDC: 72854-209
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	VVV;LOGOcrescentmoonplus
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 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	05/01/2025

Part 3 of 3

MUCINEX SINUS-MAX  SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
oxymetazoline hydrochloride solution

Product Information
Item Code (Source)	NDC: 63824-129
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		22 mL in 1 BOTTLE, PUMP; 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	10/01/2018

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)