temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure runny nose sneezing cough...
do not take more than directed (see Overdose warning ) do not take more than 12 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
store between 20-25°C (68-77°F)
Drug Facts
| Active ingredients (in each caplet) Mucinex SINUS-MAX DAY | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each caplet) Mucinex SINUS-MAX NIGHT | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
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.
croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide
croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
MAXIMUM STRENGTH
NDC 63824-204-20
FOR AGES 12+
Mucinex®
SINUS-MAX®
Actual Size
DAY
Acetaminophen - Pain Reliever
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
12
CAPLETS
Actual Size
NIGHT
Acetaminophen - Pain Reliever
Diphenhydramine HCl - Antihistamine/Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
8
CAPLETS
TOTAL
20 CAPLETS
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-204 | MUCINEX SINUS-MAX DAY NIGHT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 9 | Legacy NDC | 20230825_ae33d924-9262-41f6-964f-d8b567b3d903.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-204-40 | EA - Each | 63824-204 | c3243277-c3ec-4646-8de1-c5d1e0e6233b | 1 | 2021-09-07 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| crospovidone (15 mpa.s at 5%) | INACTIVE INGREDIENT | 68401960MK | 1 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C blue no. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C yellow no. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| methacrylic acid - ethyl acrylate copolymer (1:1) Type A | INACTIVE INGREDIENT | NX76LV5T8J | 1 | |
| mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| povidone K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | 1 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63824-204 | 63824-204-20, 63824-204-40 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| FD&C blue no. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| FD&C blue no. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET / ORAL | 165 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 4 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | GRANULE, EFFERVESCENT / ORAL | 267 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, CHEWABLE / ORAL | 140 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| methacrylic acid - ethyl acrylate copolymer (1:1) Type A | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE, DELAYED RELEASE / ORAL | 1321 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| povidones | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| povidones | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v |
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 |
|---|---|---|---|---|---|---|
| 03b0fec4-7077-07c3-e063-6394a90adb9d | ae33d924-9262-41f6-964f-d8b567b3d903 | 2023-08-24 | Warnings | 03b0fec4-7077-07c3-e063-6394a90adb9d ae33d924-9262-41f6-964f-d8b567b3d903 |
Adverse event summaries are temporarily unavailable. Other product information remains available.