FDA.reportPublic FDA data

Daytime Cold and Cough Nighttime Cold and Congestion

Manufacturer
CVS | Guardian Drug Company
Effective date
2026-03-16
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 01:50:23

Label at a glance#

ProductDaytime Cold and Cough Nighttime Cold and Congestion
Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Dosage and administration

DAYTIME do not take more than 6 doses in any 24-hour period do not exceed recommended dosage mL milliliter tsp = teaspoon Age  Dose   adults & children 12 years over   4 tsp (20 mL) every 4 hours children 6 years to under 12 years  2 tsp (10 mL) every 4 hours children under 6 years  do not use NIGHTTIME  do not take more than 6 doses in any 24-hour period do not exceed recommended dosage mL milliliter tsp = teaspo...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg 

ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 6.25 mg

Phenylephrine HCI 2.5 mg 

PURPOSE FOR DAYTIME

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Nasal decongestant

PURPOSE FOR NIGHTTIME

OTC - PURPOSE SECTION

Antihistamine / Cough suppressant

Nasal Decongestant

USE(S)

INDICATIONS & USAGE SECTION


DAYTIME

  • temporarily relieves cough due to minor
    bronchial irritation as may occur with a cold, and
    nasal congestion due to the common cold, hay
    fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay
    fever (allergic rhinitis): • sneezing • itching of the
    nose or throat • runny nose • itchy, watery eyes
  • temporarily restores freer breathing through the nose

NIGHTTIME


  • tempuradly relieves these symptoms occuring with
    a cold, hay fever or other upper respiratory allergies:
    • sneezing. itching of the nose or throat. runny nose
    • itchy, watery eyes. cough. nasal congestion

WARNINGS

WARNINGS SECTION

.

DO NOT USE

OTC - DO NOT USE SECTION

Daytime

Do not use

  • to sedate a child or to make a child sleepy
  • 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.

Nighttime

Do not use

  • to sedate a child or to make a child sleepy
  • 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 nut know if your prescription drug contains an MAOI, ask a doctor
    or pharmacist before taking this product.
  • with any other product containing diphenhydramine, even one used on skin

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION


DAYTIME

  • heart disease 
  • glaucoma 
  • diabetes 
  • thyroid disease 
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs wilt too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

 
NIGHTTIME


  • heart disease 
  • glaucoma 
  • diabetes
  • thyroid disease 
  • high blood pressure 
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

OTC - ASK DOCTOR/PHARMACIST SECTION

DAYTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers

 

NIGHTTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

DAYTIME 

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

 NIGHTTIME

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious
    condition.

IF PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION


DAYTIME

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon

Age Dose  
adults & children 12 years over 
 4 tsp (20 mL) every 4 hours
children 6 years to under 12 years
 2 tsp (10 mL) every 4 hours
children under 6 years do not use


NIGHTTIME 

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon

Age Dose  
adults & children
12 years over 
 4 tsp (20 mL) every 4 hours
children 6 years to
under 12 years
 2 tsp (10 mL) every 4 hours
children under 6 years do not use

OTHER INFORMATION

OTHER SAFETY INFORMATION


DAYTIME

  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF)
  • measuring cup provided

     

NIGHTTIME


  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF) 
  • measuring cup provided

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DAYTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

NIGHTTIME
anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red  #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY/NIGHT PACK

NDC 51316-939-04

CVS Health 

Compare to the active Ingredients in Children's Dimetapp® Cold & Cough*

Compare to the active Ingredients in Children's Dimetapp® Nighttime Cold & Cough*

 

Children's Daytime Cold & Cough

 

BROMPHENIRAMINE MALEATE
Antihistamine

DEXTROMETHORPHAN HBr

Cough suppressant


PHENYLEPHRINE HCl

Nasal decongestant


DM Liquid

Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes


Calms allergy symptoms
Soothes Cough

Alcohol Free


Grape Flavor

Ages 6 Years & Over


4 FL OZ (118 mL)


Children's Nighttime Congestion & Cold 

 

DIPHENYLHYDRAMINE HCl

Cough suppressant; Antihistamine

 

PHENYLEPHRINE HCl

Nasal decongestant


Liquid


Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes


Calms allergy symptoms
Soothes Cough


Alcohol Free


Grape Flavor

Ages 6 Years & Over


4 FL OZ (118 mL)


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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1666116{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK3
16661161 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) PackPSN3
1090463brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN3
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN3
1090463brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
16661161 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) PackSY3
16661161 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSY3
1090463brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY3
1090463brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY3
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY3
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-916-03Daytime Cold and Cough Nighttime Cold and Congestion118 mL in 1 BOTTLELIQUID118 mL1 mg in 5mL3
51316-916-03Daytime Cold and Cough Nighttime Cold and Congestion1 in 1 CARTONLIQUID5 mg in 5mL3
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion118 mL in 1 BOTTLELIQUID118 mL6.25 mg in 5mL3
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion1 in 1 CARTONLIQUID6.25 mg in 5mL3
51316-939-04Daytime Cold and Cough Nighttime Cold and Congestion1 in 1 KITKIT13

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-93951316-939-04
51316-91651316-916-03
51316-91951316-919-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
BROMPHENIRAMINE MALEATEIXA7C9ZN03ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
ndc (package): 51316-916-03
ndc (package): 51316-939-04
ndc (package): 51316-919-03
ndc (product): 51316-939
ndc11 (package): 51316091903
ndc11 (package): 51316091603
ndc11 (package): 51316093904
spl id: 1d9b6133-6f2e-4e5c-8c5a-01846d64dbbd
spl set id: 2cf361eb-6055-2364-e063-6294a90a69a1

Reported adverse events (FAERS/openFDA)#

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