Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, Doxylamine Succinate

Manufacturer
RB Health (US) LLC
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:28

Label at a glance#

ProductMUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Day:


Acetaminophen 325 mg

Guaifenesin 200 mg

Night:

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

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
Doxylamine succinate 6.25 mg............. Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.


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.

Night:


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 ■ 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

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.

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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.

OTHER SAFETY INFORMATION


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

INACTIVE INGREDIENT SECTION

Day:


Inactive ingredients
FD&C blue no. 1, gelatin, glycerin, hypromellose,
lecithin, light mineral oil, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol sorbitan
solution, titanium dioxide

Night:

Inactive ingredients
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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton labelcarton label

back labelback label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2612689{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) } PackGPCK3
26126891 daytime (acetaminophen 325 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN3
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSN3
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSN3
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD3
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCD3
26126891 daytime (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY3
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSY3
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363824999425GTIN-13: 0363824999425
EAN-13: 0363824999425
GTIN-12: 363824999425
UPC-A: 363824999425
GTIN storage (14 digits): 00363824999425
72854-217 front label.jpg
Data codeData Matrix332155672854-217 back label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72854-217-24MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels1 in 1 BLISTER PACKKIT13
72854-217-24MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels2 in 1 CARTONKIT23

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72854-21772854-217-24
72854-001
72854-002

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217338-001112785062036-10-11Drug product2026-04-07
N217338-001122572182036-10-11Drug product2026-04-07
N217338-001123701892036-10-11Drug product2026-04-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22c2088c7a36db…
2026-09-14 22:38:342026-08N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-2284e616aacf4f…
2026-08-18 06:07:402026-07N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM30MG;600MG;110MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-12-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N217338-001112785062036-10-11Drug product2026-04-07c2088c7a36db…
2026-10-15 13:18:302026-09N217338-001122572182036-10-11Drug product2026-04-07c2088c7a36db…
2026-10-15 13:18:302026-09N217338-001123701892036-10-11Drug product2026-04-07c2088c7a36db…
2026-09-14 22:38:342026-08N217338-001112785062036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001122572182036-10-11Drug product2026-04-0784e616aacf4f…
2026-09-14 22:38:342026-08N217338-001123701892036-10-11Drug product2026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N217338-001112785062036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001122572182036-10-11Drug product2026-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N217338-001123701892036-10-11Drug product2026-04-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001112785062036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001122572182036-10-11Drug product2026-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217338-001123701892036-10-11Drug product2026-04-07a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex 12HR Cold and Fever Multi-SymptomNAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC49f1f415-8017-0974-e063-6294a90a89182026-06-02WarningsExact identifier
ndc (product): 72854-001
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
ndc (package): 72854-217-24
ndc (product): 72854-217
ndc11 (package): 72854021724
spl id: 445ac12b-298b-ea9f-e063-6294a90a9531
spl set id: 38571853-992f-9998-e063-6394a90a8581

Reported adverse events (FAERS/openFDA)#

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