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
Mucus Relief Nighttime Cold Flu
- Manufacturer
- P & L Development, LLC
- Effective date
- 2023-05-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:31:12
Label at a glance#
ProductMucus Relief Nighttime Cold Flu Maximum StrengthCold Flu and Sore Throat
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed (see Overdose warning) do not take more than 6 doses in a 24-hour period measure only with dosing cup provided. Do not use any other dosing device mL = milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 mL every 4 hours children under 12 years of age: do not use
Storage and handling
each 20 mL contains: sodium 10 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCL 10 mg
Purposes
Pain reliever/fever reducer
Antihistamine/cough suppressant
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 4,000 mg of acetaminophen in 24 hours
- 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
- 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.
- 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
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or 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
- you are 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 day
- 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 (1800-222-1222) 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 a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- keep dosing cup with product
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older: 20 mL every 4 hours
- children under 12 years of age: do not use
Other information
- each 20 mL contains: sodium 10 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
anhydrous citric acid, disodium EDTA, FD&C blue #1, FD&C yellow #10, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Principal Display Panel
Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Clear & Cool® Night Time Cold & Flu*
max strength
night time cold & flu
Acetaminophen 650 mg Pain reliever / Fever reducer
Diphenhydramine HCL 25 mg Antihistamine/Cough suppressant
Phenylephrine HCL 10 mg Nasal decongestant
multi-symptom relief
- Relieves aches, fever & sore throat
- controls cough
- relieves nasal congestion
- relieves runny nose & sneezing
for ages 12 years & older
FL OZ (mL)
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
*This product is no manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Clear & Cool® Night Time Cold, & Flu
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING
Manufactured by: PL Developments
11865 S Alameda St
Lynwood, CA 90262
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0808-6 | 2023-05-18 | C162847 | 48780-1 | f386c649-c9ca-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0808-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-c9ca-0266-e053-dadaa90a7c1a | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- Mucus Relief Nighttime Cold Flu Maximum StrengthCold Flu and Sore Throat
- Acetaminophen, Diphenhydramine HCL,Phenylephrine HCL
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- D&C YELLOW NO. 10
- GLYCERIN
- PROPYL GALLATE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0808 | 49580-0808-6 |
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 |
|---|---|---|---|---|---|---|
| 94eb109f-054b-402a-be9d-6fd01d3dbad4 | 7b4b1891-83e3-48ca-9d98-94acc8de3f52 | 2023-05-18 | Warnings | 94eb109f-054b-402a-be9d-6fd01d3dbad4 7b4b1891-83e3-48ca-9d98-94acc8de3f52 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.