NIGHT TIME COUGH CHERRY- dextromethorphan hbr, doxylamine succinate liquid

NIGHT TIME COUGH CHERRY by

Drug Labeling and Warnings

NIGHT TIME COUGH CHERRY by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

QUESTIONS

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)

INGREDIENTS AND APPEARANCE

NIGHT TIME COUGH CHERRY 
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-533
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)
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-533-16	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/14/2017

Labeler - Marc Glassman, Inc. (094487477)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(68998-533)