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Night Time Cherry

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-072

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

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 • to make a child sleepy
• if you are on a sodium-restricted diet
• 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 two 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

• asthma • emphysema • glaucoma • excessive phlegm (mucus) • breathing problems • chronic bronchitis
• persistent or chronic cough • cough associated with smoking • trouble urinating due to enlarged prostate gland

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

• you get nervous, dizzy or sleepless • redness or swelling is present • new symptoms occur
• fever gets worse or lasts more than 3 days • pain or cough gets worse or lasts more than 7 days
• cough comes back or occurs with 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 this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

• take only as recommended
• use dosage cup or tablespoon (TBSP) • do not exceed 4 doses per 24 hours
age dose
adults and children 12 years and over 2 tablespoons (30 mL) every 6 hours
children 4 years to under 12 years do not use unless directed by a doctor
children under 4 years do not use
• When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other Information

• each tablespoon contains: sodium 18 mg • store at controlled room temperature

Inactive ingredients

alcohol, blue 1, citric acid, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol,
purified water, red 40, saccharin sodium, sodium citrate

Principal Display Panel

Premier Value

Night Time Cough Cherry all night cough relief

compare to the active ingredients in Vicks Nyquil Cough

Dextromethorphan HBr-cough suppressant

Doxylamine Succinate-Antihistamine

10% Alcohol

10 fl oz (296mL)

NIGHT TIME CHERRY 
dextromethorphan hydrobromide, doxylamine succinate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-072
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 
CITRIC ACID MONOHYDRATE 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SACCHARIN SODIUM ANHYDROUS 
TRISODIUM CITRATE DIHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-072-01296 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/2009
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - P & L Development, LLC (800014821)

Revised: 10/2015
 
Chain Drug Consortium, LLC

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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