DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION- brompheniramine maleate, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit

Daytime Cold and Cough Nighttime Cold and Congestion by

Drug Labeling and Warnings

Daytime Cold and Cough Nighttime Cold and Congestion by is a Otc medication manufactured, distributed, or labeled by CVS, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Brompheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg 

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

Diphenhydramine HCI 6.25 mg

Phenylephrine HCI 2.5 mg 

PURPOSE FOR DAYTIME

Antihistamine

Cough suppressant

Nasal decongestant

PURPOSE FOR NIGHTTIME

Antihistamine / Cough suppressant

Nasal Decongestant

USE(S)

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

.

DO NOT USE

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

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

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

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

• 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

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

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 & children12 years over: 4 tsp (20 mL) every 4 hours
• children 6 years tounder 12 years: 2 tsp (10 mL) every 4 hours
• children under 6 years: do not use

OTHER 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

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

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)

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION 
brompheniramine maleate, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-939

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-939-04	1 in 1 KIT; Type 0: Not a Combination Product	01/31/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

CHILDRENS DAYTIME COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Item Code (Source)	NDC: 51316-916
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-916-03	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/03/2025

Part 2 of 2

CHILDRENS NIGHTTIME CONGESTION AND COLD 
diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Item Code (Source)	NDC: 51316-919
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-919-03	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/31/2025

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(51316-939)