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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL 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) } Pack | GPCK | 3 |
| 2612689 | 1 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) Pack | PSN | 3 |
| 1426334 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 3 |
| 707195 | acetaminophen 325 MG / guaiFENesin 200 MG Oral Capsule | PSN | 3 |
| 1426334 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 3 |
| 707195 | acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule | SCD | 3 |
| 2612689 | 1 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) Pack | SY | 3 |
| 1426334 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 3 |
| 707195 | APAP 325 MG / Guaifenesin 200 MG Oral Capsule | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0363824999425 | GTIN-13: 0363824999425 EAN-13: 0363824999425 GTIN-12: 363824999425 UPC-A: 363824999425 GTIN storage (14 digits): 00363824999425 | 72854-217 front label.jpg |
| Data code | Data Matrix | 3321556 | 72854-217 back label.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72854-217-24 | MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 72854-217-24 | MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | 2 in 1 CARTON | KIT | 2 | 3 |
Products#
Every source-derived product name is available through these pages.
- MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels
- Acetaminophen, Guaifenesin, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Mucinex Rapid Clear Daytime Pain, Headache and Mucus Congestion
- Acetaminophen, Guaifenesin
- GUAIFENESIN
- HYPROMELLOSES
- POVIDONE
- ACETAMINOPHEN
- GELATIN
- GLYCERIN
- WATER
- TITANIUM DIOXIDE
- SORBITOL SOLUTION
- LECITHIN, SUNFLOWER
- LIGHT MINERAL OIL
- PROPYLENE GLYCOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C BLUE NO. 1
- Mucinex Rapid Clear Nighttime Headache, Cough and Fever
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- D&C YELLOW NO. 10
- ISOPROPYL ALCOHOL
- POLYETHYLENE GLYCOL 400
- 1,4-SORBITAN
- SORBITOL
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- MANNITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72854-217 | 72854-217-24 |
| 72854-001 | |
| 72854-002 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | |
| N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | |
| N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | 30MG;600MG;110MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2025-12-22 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 11278506 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 12257218 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217338-001 | 12370189 | 2036-10-11 | Drug product | 2026-04-07 | a50c72e98297… |
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 12HR Cold and Fever Multi-Symptom | NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 49f1f415-8017-0974-e063-6294a90a8918 | 2026-06-02 | Warnings | 72854-001 |
| MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | RB Health (US) LLC | 38571853-992f-9998-e063-6394a90a8581 | 2025-11-24 | Warnings | 72854-217-24 72854-217 72854021724 445ac12b-298b-ea9f-e063-6294a90a9531 38571853-992f-9998-e063-6394a90a8581 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

