Mucinex Nightshift Sinus

Manufacturer
RB Health (US) LLC
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:01:08

Label at a glance#

ProductMucinex Nightshift Sinus Maximum Strength
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, TRIPROLIDINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each caplet)


Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

OTC - QUESTIONS SECTION


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

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2549034acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral TabletPSN2
2549034acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSCD2
2549034APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-209-20Mucinex Nightshift SinusMaximum Strength10 in 1 BLISTER PACKTABLET, COATED102
72854-209-20Mucinex Nightshift SinusMaximum Strength2 in 1 CARTONTABLET, COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-209MUCINEX NIGHTSHIFT SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC]2Current NDC, 2 package rows20250519_35322238-d498-1a52-e063-6394a90ac9c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-20972854-209-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
ndc (package): 72854-209-20
ndc (product): 72854-209
ndc11 (package): 72854020920
spl id: 35322ca5-3819-1ec8-e063-6394a90a262f
spl set id: 35322238-d498-1a52-e063-6394a90ac9c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.