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
Nighttime Cold and Flu
- Manufacturer
- Rite Aid Corporation
- Effective date
- 2026-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:18
Label at a glance#
ProductNighttime Cold and Flu
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections
Dosage and administration
do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hours 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 and over: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use
Storage and handling
each 20 mL contains : Sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Websitewww.riteaid.com
www.riteaid.com
www.riteaid.comLabel 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/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
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such 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
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
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-hours 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 and over: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Other information
- each 20 mL contains: Sodium 12 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, 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® Night Time Cold & Flu*
MAXIMUM STRENGTH
NIGHT TIME
COLD & FLU
MULTI-SYMPTOM RELIEF
PAIN RELIEVER / FEVER REDUCER
ANTIHISTAMINE / COUGH SUPPRESSANT
NASAL DECONGESTANT
ACETAMINOPHEN 650 mg
DIPHENHYDRAMINE HCl 25 mg
PHENYLEPHRINE HCl 10 MG
Temporarily relieves aches,fever, sore throat, nasal congestion, runny nose & sneezing
Controls cough
For ages 12 & over
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor or Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
Product Label
Package label
Package label
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold and Flu
- Acetaminophen Diphenhydramine HCl Phenylephrine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- EDETATE CALCIUM DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYL GALLATE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-6859 | 11822-6859-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-09 | monthly-update | 2026-06-03 17:45:40 |
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 |
|---|---|---|---|---|---|---|
| a05b1686-480e-4b49-9e03-c7045e049180 | dc315218-bdd9-44b4-ab0a-71077fe0a73c | 2026-01-02 | Warnings | a05b1686-480e-4b49-9e03-c7045e049180 dc315218-bdd9-44b4-ab0a-71077fe0a73c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.