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NIGHT TIME COUGH CHERRY by Marc Glassman, Inc.

Medically reviewed on July 14, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: Marc Glassman, Inc.
NDC Code: 68998-533

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)

NIGHT TIME COUGH CHERRY 
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-533
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
CHERRY 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL 1500 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68998-533-16355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/14/2017
Labeler - Marc Glassman, Inc. (094487477)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(68998-533)

 
Marc Glassman, Inc.

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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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