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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2549034 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet | PSN | 2 |
| 2549034 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SCD | 2 |
| 2549034 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72854-209-20 | Mucinex Nightshift SinusMaximum Strength | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 2 | |
| 72854-209-20 | Mucinex Nightshift SinusMaximum Strength | 2 in 1 CARTON | TABLET, COATED | 2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72854-209 | MUCINEX NIGHTSHIFT SINUS MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC] | 2 | Current NDC, 2 package rows | 20250519_35322238-d498-1a52-e063-6394a90ac9c4.zip |
Products#
Every source-derived product name is available through these pages.
- Mucinex Nightshift Sinus Maximum Strength
- Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride
- HYPROMELLOSE, UNSPECIFIED
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- TITANIUM DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- CROSCARMELLOSE SODIUM
- POVIDONE, UNSPECIFIED
- ACETAMINOPHEN
- POLYSORBATE 80
- CROSPOVIDONE, UNSPECIFIED
- TRIPROLIDINE HYDROCHLORIDE
- TRIPROLIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-209 | 72854-209-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | RB Health (US) LLC | 35322238-d498-1a52-e063-6394a90ac9c4 | 2025-05-15 | Warnings | 72854-209-20 72854-209 72854020920 35322ca5-3819-1ec8-e063-6394a90a262f 35322238-d498-1a52-e063-6394a90ac9c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
