Indications and uses
temporarily relieves these common cold and flu symptoms minor aches and pains headache sore throat sneezing runny nose nasal congestion cough controls cough to help your child get to sleep temporarily reduces fever
Multi Symptom NightTime Cold
- Manufacturer
- CVS Pharmacy
- Effective date
- 2022-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:47:05
Label at a glance#
ProductMulti Symptom NightTime Cold
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter dose as follows or as directed...
Storage and handling
each 10 mL contains : sodium 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 10 mL)
Acetaminophen 325 mg
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Purpose
Pain reliever / fever reducer
Antihistamine / Cough suppressant
Nasal Decongestant
Uses
- temporarily relieves these common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- sneezing
- runny nose
- nasal congestion
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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
- in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product
- with any other drug containing diphenhydramine, even one used on skin.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product
- to make a child sleepy
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfain
- taking sedative or tranquilizers
When using these products
- do not use more than directed
- marked drowsiness may occur
- excitablity may occur, especially in children
- sedatives and tranquilizer may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or last more than 5 days
- redness or swelling is present
- new symptoms occurs
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions.
.
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 even if you do not notice any sign or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- do not give more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL every 4 hours
- children under 6 years of age: do not use
Other information
- each 10 mL contains: sodium 5 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
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**
Children's
multi-symptom
Nighttime Cold
ACETAMINOPHEN 325 mg (pain reliever / fever reducer)
DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)
PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)
Relieves:
Nasal congestion
Reduces fever
Soothes cough and sore throat
Ages 6 to 11 Years
Berry Flavor Liquid
Dosage Cup Included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com® 1-800-SHOP CVS
Product Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-506-04 | 2022-11-21 | C162847 | 48780-1 | d6a99b39-50e0-a426-e053-dadaa90af4c2 | DRUG FACTS |
| 69842-506-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-50e0-a426-e053-dadaa90af4c2 | DRUG FACTS |
Products#
Every source-derived product name is available through these pages.
- Multi Symptom NightTime Cold
- Acetaminophen Diphenhydramine HCI Phenylephrine HCI
- 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 |
|---|---|
| 69842-506 | 69842-506-04 |
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 |
|---|---|---|---|---|---|---|
| 9f35dd1a-cc20-4aed-824f-8604692d4643 | 991019f8-b4c2-45b8-ad71-fe099e6d99a7 | 2022-11-21 | Warnings | 9f35dd1a-cc20-4aed-824f-8604692d4643 991019f8-b4c2-45b8-ad71-fe099e6d99a7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.