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 & over30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Daytime Cough

adults & children 12 yrs & over30 ml (2 TBSP) every 6-8 hrs
children 6 to under 12 yrs15 ml (1 TBSP) every 6-8 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-031
Packaging
#Item CodePackage Description
1NDC:41250-031-011 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 296 mL
Part 21 BOTTLE 296 mL
Part 1 of 2
NITETIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Item Code (Source)NDC:41250-668
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 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 DIHYDRATE 
SODIUM CITRATE 
Product Characteristics
ColorRED (clear dark) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-668-38296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/03/2003
Part 2 of 2
DAY TIME COUGH  NON DROWSY
dextromethorphan hbr liquid
Product Information
Item Code (Source)NDC:41250-473
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 DIHYDRATE 
SODIUM CITRATE 
Product Characteristics
ColorORANGE (light orange clear) Score    
ShapeSize
FlavorCITRUS (menthol) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-473-38296 mL in 1 BOTTLE
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 finalpart34101/10/1992
Labeler - Meijer Distribution Inc (006959555)

Revised: 02/2012
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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