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day time nitetime cough

Dosage form: kit
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL; DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL
Labeler: Meijer Distribution Inc
NDC Code: 41250-031

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.

Meijer Distribution, Inc. Daytime Cough/Nite Time Cough Drug Facts

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

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 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 this product.
to make a child sleepy (Nighttime Cough only)

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 for 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 hours

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 6-8 hrs
children 6 to under 12 yrs	15 ml (1 TBSP) every 6-8 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 TBSP of Nighttime Cough contains: sodium 16 mg
each TBSP of Daytime Cough contains: sodium 13 mg

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 for DayTime Cough

Compare to Vicks® DayQuil® Cough active ingredient

Non-Drowsy

Citrus Flavor

DayTime Cough

Cough Suppressant

All Day Cough Relief

up to 8 Hours

Dextromethorphan HBr - cough

Alcohol Free / Antihistamine Free

Principal Display Panel for NiteTime Cough

Compare to Vicks® NyQuil® Cough active ingredients

Cherry

NiteTime Cough

Cough Suppressant, Antihistamine

All Night Cough Relief

Dextromethorphan HBr - cough

Doxylamine Succinate - sneezing, runny nose

ALCOHOL 10%

DayTime Cough/NiteTime Cough Package Image 1

DayTime Cough/NiteTime Cough Package Image 2

DAY TIME NITETIME COUGH
dextromethorphan hbr, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-031

Packaging
#	Item Code	Package Description
1	NDC:41250-031-01	1 KIT (KIT) in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	296 mL
Part 2	1 BOTTLE	296 mL

Part 1 of 2

NITETIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Item Code (Source)	NDC:41250-668
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE)	DOXYLAMINE SUCCINATE	6.25 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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 DIHYDRATE
SODIUM CITRATE

Product Characteristics
Color	RED (clear dark)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:41250-668-38	296 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/03/2003

Part 2 of 2

DAY TIME COUGH NON DROWSY
dextromethorphan hbr liquid

Product Information
Item Code (Source)	NDC:41250-473
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM DIHYDRATE
SODIUM CITRATE

Product Characteristics
Color	ORANGE (light orange clear)	Score
Shape		Size
Flavor	CITRUS (menthol)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:41250-473-38	296 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/15/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/10/1992

Labeler - Meijer Distribution Inc (006959555)

Revised: 02/2012

Document Id: e49d96a0-eaeb-40a3-bebc-dd80a44039a3

Set id: e49d96a0-eaeb-40a3-bebc-dd80a44039a3

Version: 1

Effective Time: 20120207

Meijer Distribution Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

day time nitetime cough

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