Indications and uses
temporarily relieves these common cold/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
Cold and Flu
- Manufacturer
- CVS Pharmacy
- Effective date
- 2019-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:03:50
Label at a glance#
ProductCold and Flu Nighttime
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, 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 any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL= milliliter 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 HCI 25 mg
Phenylephrine HCI 10 mg
Purposes
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal dscongestant
Uses
- temporarily relieves these common cold/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 every day 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 non-prescription). 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 as 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
- sedatives or tranquilizers
- the blood thinning drug warfarin
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 (1-800-222-1222) 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 any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- 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
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*
MAXIMUM STRENGTH
Nighttime
Cold & Flu
ACETAMINOPHEN - Pain reliever;Fever reduce
DIPHENHYDRAMINE - Anthihistamine;Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Multi-Symptom Nighttime
- Relieves headache, fever & sore throat
- Controls cough
- Relieves nasal congestion
- Relieves runny nose & sneezing
Cool Mint Flavor
For ages 12 & over
FL OZ (mL)
*This product is not 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.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com®
Product Label
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Nighttime
- Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- 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 |
|---|---|
| 69842-808 | 69842-808-06 |
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 |
|---|---|---|---|---|---|---|
| 34cc11a3-cf3d-40e4-9998-de1a7e3534c5 | f8f1027b-a605-4f16-90e0-5cbd82fc8c48 | 2019-10-31 | Warnings | 34cc11a3-cf3d-40e4-9998-de1a7e3534c5 f8f1027b-a605-4f16-90e0-5cbd82fc8c48 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.