Indications and uses
temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
Mucinex Fast-Max
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2016-05-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:25:34
Label at a glance#
ProductMucinex Fast-Max Night Time Cold and Flu Clear and Cool
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 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older; 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use
Storage and handling
each 20 mL contains: sodium 9 mg store between 20-25°C (68-77°F) dosing cup provided do not refrigerate
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 20 mL) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 25 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using the 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.
- with any other drug containing diphenhydramine, even one used on the skin
- 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
- breathing problems 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
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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.
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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older; 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Other Information
- each 20 mL contains:
sodium 9 mg - store between 20-25°C (68-77°F)
- dosing cup provided
- do not refrigerate
Inactive ingredients
anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xantham gum
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
Made in England
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
NDC 63824-510-66
MAXIMUM STRENGTH*
Mucinex®
FAST-MAX®
NIGHT TIME
COLD & FLU
CLEAR & COOL™
Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
- Relieves Aches, Fever & Sore Throat
- Controls Cough
- Relieves Nasal Congestion
- Relieves Runny Nose & Sneezing
6 FL OZ (180mL)
FOR AGES 12+
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-510-66 | 2023-11-29 | C162847 | 48780-1 | 9d75b9d0-77e0-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Night Time Cold & Flu Clear & Cool ™ |
| 63824-510-66 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-77e0-f424-e053-dadaa90a57ce | Mucinex® Fast-Max ® Night Time Cold & Flu Clear & Cool ™ |
Products#
Every source-derived product name is available through these pages.
- Mucinex Fast-Max Night Time Cold and Flu Clear and Cool
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- anhydrous citric acid
- D&C yellow no. 10
- edetate disodium
- FD&C blue no. 1
- glycerin
- propyl gallate
- propylene glycol
- sodium benzoate
- sodium citrate, unspecified form
- sorbitol
- sucralose
- water
- xanthan gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-510 | 63824-510-66 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 0b52e6dc-4d96-5c78-e063-6294a90abfee | fe424174-6b21-4ad5-a1c2-16e5775cf516 | 2023-11-29 | Warnings | fe424174-6b21-4ad5-a1c2-16e5775cf516 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.