NIGHTTIME COUGH RELIEF- dextromethorphan hbr, doxylamine succinate solution 
Rite Aid Corporation

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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Rite Aid Corporation Nighttime Cough Relief Drug Facts

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 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 the active ingredients of Vicks® NyQuil® Cough

nighttime

cough relief

dextromethorphan HBr

doxylamine succinate

cough suppressant

antihistamine

cherry flavor

all night cough relief

multi-symptom relief

10% ALCOHOL

8 FL OZ (237 mL)

nighttime cough relief Image 1
nighttime cough relief Image 2
NIGHTTIME COUGH RELIEF 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0668
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg  in 30 mL
Inactive Ingredients
Ingredient Name Strength
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color RED (Dark Red) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-0668-1 237 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:11822-0668-2 355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/07/2002
Labeler - Rite Aid Corporation (014578892)

Revised: 4/2016
Document Id: 923a8114-4f1d-441a-9175-9337b1070087
Set id: 1aa5fae2-a8ba-43ec-a22c-6385a5b902be
Version: 2
Effective Time: 20160414
 
Rite Aid Corporation