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

Mucinex Nightshift Sinus by

Drug Labeling and Warnings

Mucinex Nightshift Sinus 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 caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Triprolidine HCl 1.25 mg

INDICATIONS & USAGE

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

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

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)

QUESTIONS

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

INACTIVE INGREDIENT

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

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

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

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	NDC: 72854-209-20	2 in 1 CARTON	05/01/2025
1		10 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

Labeler - RB Health (US) LLC (081049410)