DAYTIME COUGH NIGHTTIME COUGH- dextromethorphan hbr, doxylamine succinate   
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Pharmacy, Inc. DayTime Cough NightTime Cough Drug Facts

Active ingredient for Nighttime Cough (in each 30 ml dose cup)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose for Nighttime Cough

Cough suppressant

Antihistamine

Active ingredient for Daytime Cough (in each 15 ml tablespoon)

Dextromethorphan HBr 15 mg

Purpose for Daytime Cough

Cough suppressant

Uses

temporarily relieves:

cough due to minor throat and bronchial irritation
runny nose and sneezing (Nighttime Cough only)

Warnings

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 these products.
to make a child sleepy (Nighttime Cough only)

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland
persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using these products

do not use more than directed

In addition, when using Nighttime Cough:

may cause marked drowsiness
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
avoid alcoholic drinks

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, 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.

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

Directions

take Nighttime Cough or Daytime Cough only as recommended
use dose cup
do not exceed 4 doses per 24 hrs

Nighttime Cough

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Daytime Cough

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 to 8 hrs

children 6 to under 12 yrs

15 ml (1 TBSP) every 6 to 8 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

each 30 ml dose cup of Nighttime Cough contains: sodium 32 mg
each TBSP of Daytime Cough contains: sodium 13 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime Cough alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime Cough anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

TWIN PACK

Compare to the active ingredient in Vicks® DayQuil® Cough

Non-Drowsy

DAYTIME COUGH

COUGH RELIEF

CITRUS BLEND FLAVOR

All Day Cough Relief up to 8 hours

Cough Suppressant

Dextromethorphan HBr – cough

ALCOHOL FREE

Compare to the active ingredients in Vicks® NyQuil® Cough

NIGHTTIME COUGH

COUGH RLIEF

CHERRY FLAVOR

ALL NIGHT Cough Relief

Antihistamine, Cough suppressant

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

ALCOHOL 10%

DayTime Cough NightTime Cough Carton Image 1
DayTime Cough NightTime Cough Carton Image 2
DAYTIME COUGH NIGHTTIME COUGH 
dextromethorphan hbr, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-031
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-031-021 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 355 mL
Part 21 BOTTLE 355 mL
Part 1 of 2
NIGHTTIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Item Code (Source)NDC:59779-668
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorRED (Dark Red) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-668-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/23/2002
Part 2 of 2
DAYTIME COUGH 
dextromethorphan hbr liquid
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorORANGE (light) Score    
ShapeSize
FlavorCITRUS (blend) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 KIT
1355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2012
Labeler - CVS Pharmacy (062312574)

Revised: 11/2012
 
CVS Pharmacy