NITETIME COUGH DAYTIME COUGH- dextromethorphan hydrobromide, doxylamine succinate 
Meijer Distribution Inc

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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Meijer Distribution, Inc. NiteTime Cough DayTime Cough Drug Facts

Nighttime Cough
Active ingredients (in each 30 mL)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms:

•
cough due to minor throat and bronchial irritation
•
runny nose and sneezing

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 this product.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 only as directed
•
only use the dose cup provided
•
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

•
each 30 mL contains: sodium 32 mg
•
store at 20-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Daytime Cough
Active ingredient (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

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 this product.

Ask a doctor before use if you have

•
cough that occurs with too much phlegm (mucus)
•
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 only as directed
•
only use the dose cup provided
•
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6-8 hrs

children 6 to under 12 yrs

15 mL every 6-8 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

Other information

•
each 15 mL contains: sodium 13 mg
•
store at 20-25°C (68-77F)
•
does not meet USP requirements for light resistant packaging

Inactive ingredients

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 – NiteTime Cough

COMBO PACK

Compare to Vicks® NyQuil® Cough active ingredients

nitetime cough

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate | Antihistamine

All Night Cough Relief

Cherry Flavor

ALCOHOL 10%

Relieves: Cough, Sneezing, Runny Nose

12 FL OZ (355 mL)

Principal Display Panel – DayTime Cough

COMBO PACK

Compare to Vicks® DayQuil® Cough active ingredient

NON-DROWSY

daytime cough

Dextromethorphan HBr

Cough Suppressant

All Day Cough Relief

Citrus Blend Flavor

Alcohol Free

Antihistamine Free

Powerful Cough Relief for up to 8 hours

12 FL OZ (355 mL)

031-6e-daytime-nitetime.jpg
NITETIME COUGH DAYTIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-031
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-031-021 in 1 KIT; Type 0: Not a Combination Product02/13/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 355 mL
Part 21 BOTTLE 355 mL
Part 1 of 2
NITETIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate solution
Product Information
Item Code (Source)NDC:41250-668
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorRED (Dark Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-668-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/03/2003
Part 2 of 2
DAYTIME COUGH  NON DROWSY
dextromethorphan hydrobromide solution
Product Information
Item Code (Source)NDC:41250-473
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorORANGE (light) Score    
ShapeSize
FlavorCITRUS (blend) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-473-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/13/2013
Labeler - Meijer Distribution Inc (006959555)

Revised: 7/2023
Document Id: 3777e445-3c1d-46a9-bde0-5cd4a8dae1bc
Set id: d9bf2076-4d3f-4118-ab38-54ab61631716
Version: 6
Effective Time: 20230711
 
Meijer Distribution Inc