Indications and uses
temporarily relieves these common cold and flu symptoms: nasal congestion headache minor aches and pains sore throat runny nose and sneezing temporarily reduces fever
Mucinex Fast-Max
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2014-12-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:34:21
Label at a glance#
ProductMucinex Fast-Max Night Time Cold and Flu
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure10 sections
Dosage and administration
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
Storage and handling
store at 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 25 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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.
- with any other drug containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- 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
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion 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
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- 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
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions?
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
PRINCIPAL DISPLAY PANEL - 20 Caplet Carton
MAXIMUM STRENGTH*
NDC 63824-550-20
Mucinex®
FAST-MAX®
NIGHT TIME
Cold & Flu
Acetaminophen • Pain Reliever/Fever Reducer
Diphenhydramine HCl • Antihistamine
Phenylephrine HCl • Nasal Decongestant
NEW!
- Relieves Aches, Fever & Sore Throat
- Relieves Nasal Congestion
- Relieves Runny Nose & Sneezing
For Ages 12+
20 CAPLETS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-550-20 | 2023-09-07 | C162847 | 48780-1 | 9d75b9d0-3a12-f424-e053-dadaa90a57ce | Mucinex ® Fast-Max ® Night Time Cold and Flu |
| 63824-550-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3a12-f424-e053-dadaa90a57ce | Mucinex ® Fast-Max ® Night Time Cold and Flu |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-550-20 | EA - Each | 63824-550 | bcddd54b-f72d-4eb7-ae4d-778fcaa60ed0 | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | 2 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 2 |
Products#
Every source-derived product name is available through these pages.
- Mucinex Fast-Max Night Time Cold and Flu
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Acetaminophen
- Diphenhydramine Hydrochloride
- Diphenhydramine
- Phenylephrine Hydrochloride
- Phenylephrine
- starch, corn
- croscarmellose sodium
- crospovidone
- FD&C blue no. 1
- aluminum oxide
- hypromelloses
- magnesium stearate
- cellulose, microcrystalline
- polydextrose
- polyethylene glycols
- povidones
- silicon dioxide
- stearic acid
- titanium dioxide
- triacetin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-550 | 63824-550-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| triacetin | TRIACETIN | XHX3C3X673 | SYSTEM / TRANSDERMAL | 22.1 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| povidones | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| povidones | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| povidones | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| triacetin | TRIACETIN | XHX3C3X673 | CAPSULE, EXTENDED RELEASE / ORAL | 467 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| povidones | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| povidones | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 017e4c93-c731-8b4e-e063-6294a90a6ef5 | 7b4b309b-3726-4a14-b7e6-64469b994322 | 2023-07-27 | Warnings | 7b4b309b-3726-4a14-b7e6-64469b994322 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.