FDA.reportPublic FDA data

Multi Symptom Cold and Multi Symptom Nighttime Cold

Manufacturer
CVS Pharmacy
Effective date
2025-09-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:13:38

Label at a glance#

ProductMulti Symptom Cold and Multi Symptom Nighttime Cold Childrens
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Nighttime 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 Daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive temporarialy relieves cough due to mino...

Dosage and administration

Nighttime 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 a...

Storage and handling

Nighttime each 10 mL contains : sodium 6 mg store between 20-25ºC (68-77ºF). Do not refrigerate. Daytime each 5 mL contains : 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients for Nighttime (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Diphenhydramine HCI 12.5 mg

Phenylephrine HCI 5 mg

Active ingredients for Daytime (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose for Nighttime

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Antihistamine / Cough suppressant

Nasal Decongestant

Purpose for Daytime

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Nighttime

  • 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

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • temporarialy relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose

Warnings

WARNINGS SECTION

NIGHTTIME

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

OTC - DO NOT USE SECTION

Nighttime

  • 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

Daytime

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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 giving this product. 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Nighttime

  • 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)

Daytime

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Nighttime

  • taking the blood thinning drug warfain
  • taking sedative or tranquilizers

When using these products

OTC - WHEN USING SECTION

Nighttime

  • do not use more than directed
  • marked drowsiness may occur
  • excitablity may occur, especially in children
  • sedatives and tranquilizer may increase drowsiness

Daytime

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

Nighttime

  • 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.

Daytime

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Nighttime

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.

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Nighttime

  • 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

Daytime

  • do not take more than 6 doses in any 24-hours period
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • keep dosing cup with product
  • dose as follows, or as directed by a doctor
  • mL = milliliter
Age Dose 
 children 6 years to under 12 years 10 mL every 4 hours
 children 4 years to under 6 years 5 mL every 4 hours
 children under 4 years do not use

Other information

STORAGE AND HANDLING SECTION

Nighttime

  • each 10 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Daytime

  • each 5 mL contains: 5 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Nighttime

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

Daytime

citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Mucinex® Children's Multi-Symptom Cold & Night Time Multi-Symptom Cold active ingredient†

Children's

NIGHTTIME MULTI-SYMPTOM COLD

Acetaminophen 325 mg Pain Reliever, Fever Reducer

Diphenhydramine HCI 12.5 mg Antihistamine,Cough Suppressant

Phenhydramine HCI 5 mg Nasal Decongestant

 Relieves:

Nasal and chest congestion

Reduces Fever

Soothes Cough and Sore Throat

No Added Alcohol

Berry Flavor 

Ages 6-11 years

Dosage Cup Included

Ages 6 - 11 Years

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 Mucinex® Children's Multi-Symptom Cold & Night Time Multi-Symptom Cold.

DAYTIME

Children's

DAYTIME MULTI-SYMPTOM COLD

Dextromethorphan HBr 5 mg Cough Suppressant

Guaifenesin 100 mg Expectorant

Phenylephrine HCI 2.5 mg Nasal Decongestant

Relieves: Stuffy nose, Cough, Chest congestion

Breaks up Mucus

No Added Alcohol

Berry Flavor 

Dosage cup included

Ages 4 to 11 years

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

1-800-SHOP CVS

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Children's Daytime Multi-Symptom Cold Nighttime Multi-Symptom Cold Berry Flavor
CVS Children's Daytime Multi-Symptom Cold Nighttime Multi-Symptom Cold Berry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2637728{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK6
26377281 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) PackPSN6
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN6
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN6
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD6
26377281 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSY6
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY6
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY6
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY6
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY6
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY6
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY6
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-606-04Multi Symptom Cold and Multi Symptom Nighttime ColdChildrens118 mL in 1 BOTTLE, PLASTICLIQUID118 mL5 mg in 10mL6
69842-607-04Multi Symptom Cold and Multi Symptom Nighttime ColdChildrens118 mL in 1 BOTTLE, PLASTICLIQUID118 mL5 mg in 5mL6
69842-820-08Multi Symptom Cold and Multi Symptom Nighttime ColdChildrens1 in 1 KITKIT16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-82069842-820-08
69842-60769842-607-04
69842-60669842-606-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE CALCIUM DISODIUM25IH6R4SGFIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi Symptom Cold and Multi Symptom Nighttime Cold ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCICVS Pharmacyebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e2025-09-12WarningsExact identifier
ndc (package): 69842-606-04
ndc (package): 69842-820-08
ndc (package): 69842-607-04
ndc (product): 69842-820
ndc11 (package): 69842060704
ndc11 (package): 69842082008
ndc11 (package): 69842060604
spl id: 6c0a3bbd-d6cc-4c17-a731-7d6f801daa77
spl set id: ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.