NIGHTTIME COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid 
Walgreen Company

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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Walgreen Co. Nighttime Cough Drug Facts

Active ingredient (in each 15 mL tablespoon)

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms:

cough
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.
to make a child sleepy

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 this product

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
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 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.

Directions

take only as recommended
use dose cup
do not exceed 4 doses per 24 hours

adults and children 12 years and over

30 mL (2 TBSP) every 6 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

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

Other information

each TBSP contains: sodium 15 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, 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

Compare to NyQuil® Cough active ingredients

See Labeling Changes

NightTime Cough

All Night Cough Relief

Cough Suppressant, Antihistamine

Dextromethorphan HBr – Cough

Doxylamine Succinate – Sneezing, Runny Nose

Cherry Flavor

10% Alcohol

Nighttime Cough Label

Nighttime Cough Label

NIGHTTIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0668
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 
SODIUM CITRATE 
Product Characteristics
ColorRED (Dark Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0668-30177 mL in 1 BOTTLE
2NDC:0363-0668-38296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/16/2002
Labeler - Walgreen Company (008965063)

Revised: 11/2012
Document Id: ed67c35e-c7e2-4240-95fa-1fcbd1f2ba13
Set id: b39a541d-4d8e-4bb5-8e36-a6f716819dd4
Version: 3
Effective Time: 20121115
 
Walgreen Company