temporarily relieves these common cold and flu symptoms: cough minor aches and pains headache nasal congestion sore throat runny nose (NIGHT TIME only) sneezing (NIGHT TIME only) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only) controls cough to help you get to sleep (NIGHT TIME only) temporarily reduces f...
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 older: 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 FAST-MAX DAY TIME Severe Cold | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each caplet) Mucinex FAST-MAX NIGHT TIME Cold & Flu | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| 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 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.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
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 3350, polyvinyl alcohol, povidone, talc, titanium dioxide
croscarmellose sodium, crospovidone, FD&C blue no. 1, FD&C blue no. 2, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
MAXIMUM STRENGTH*
NDC 63824-557-30
Mucinex®
FAST-MAX®
DAY
TIME
SEVERE COLD
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
20 CAPLETS
NIGHT
TIME
COLD & FLU
Acetaminophen - Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/
Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
10 CAPLETS
FOR AGES 12+
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-557-30 | 2023-09-07 | C162847 | 48780-1 | 9d75b9d0-ac51-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength |
| 63824-557-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ac51-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-557-30 | EA - Each | 63824-557 | da184aa2-67ae-4ce8-ba72-a77fb6b581ac | 1 | 2017-09-11 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 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 glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 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 |
|---|---|
| 63824-557 | 63824-557-30 |
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 |
|---|---|---|---|---|---|---|
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| talc | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | INJECTION / INTRA-ARTICULAR | 56 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| methacrylic acid - ethyl acrylate copolymer (1:1) type a | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 570 mg | ||
| methacrylic acid - ethyl acrylate copolymer (1:1) type a | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE / ORAL | 245 mg | ||
| FD&C blue no. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, DELAYED RELEASE / ORAL | 0.22 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| FD&C blue no. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, CHEWABLE / ORAL | 3 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, COATED / ORAL | 0.5 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | GUM, CHEWING / ORAL | 360 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| povidones | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 3059 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 160 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, EXTENDED RELEASE / ORAL | 61 mg | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| methacrylic acid - ethyl acrylate copolymer (1:1) type a | METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | CAPSULE, COATED PELLETS / ORAL | 32 mg | ||
| talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| FD&C yellow no. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| povidones | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg |
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 |
|---|---|---|---|---|---|---|
| 017e5a9a-f419-dc70-e063-6294a90a649b | fa232c72-41ec-40b9-973d-5ba1b06b0614 | 2023-07-27 | Warnings | fa232c72-41ec-40b9-973d-5ba1b06b0614 |
Adverse event summaries are temporarily unavailable. Other product information remains available.