NIGHT TIME COUGH CHERRY - dextromethorphan hbr, doxylamine succinate liquid 
Marc Glassman, 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.

----------

Drug Facts

Active ingredients (in each 30 mL dose cup)

Dextromethorphan HBr USP 30 mg

Doxylamine succinate USP 12.5 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 sleep

Ask a doctor before use if you have

• glaucoma 
• excessive phlegm (mucus)  
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
• a sodium-restricted diet

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 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

• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
• mL = milliliter; TBSP = tablespoon

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 ensure correct dosing

Other information

each 30 mL dose cup contains: sodium 35 mg

• store at 20° to 25°C (68° to 77°F)

TAMPER EVIDENT: do not use if printed shrinkband is missing or broken.

  Failure to follow these warnings could result in serious consequences

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

Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL Bottle)

NDC 68998-533-16
 *Compare to the active ingredients in
Vicks® NyQuil® Cough
Marcs®

cherry
Night Time
COUGH
Dextromethorphan HBr (Cough suppressant)
Doxylamine succinate (Antihistamine)

  • Cough
  • Sneezing, Runny Nose

Alcohol 10% 12 FL OZ (355 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL Bottle)

NIGHT TIME COUGH CHERRY 
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-533
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)  
CHERRY (UNII: BUC5I9595W)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68998-533-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/201709/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/14/201709/01/2021
Labeler - Marc Glassman, Inc. (094487477)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(68998-533)

Revised: 11/2020
 
Marc Glassman, Inc.