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Name:Night Time Cough Cherry
Manufacturer:Duane Reade
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NIGHT TIME COUGH CHERRY  - dextromethorphan hydrobromide and doxylamine succinate liquid 
Duane Reade

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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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

Childrens Allergy diphenhydramine HCl

Antihistamine

Cherry Flavor

Relieves: runny nose; itchy, watery eyes; itchy throat; sneezing

See new dosing information

4 FL OZ (118mL)

Image of Label



NIGHT TIME COUGH CHERRY 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67732-025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 135 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
CITRIC ACID MONOHYDRATE  
HIGH FRUCTOSE CORN SYRUP  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
SACCHARIN SODIUM ANHYDROUS  
SODIUM CITRATE  
Product Characteristics
Color red (Red 40) , blue (Blue 1) Score     
Shape Size
Flavor CHERRY (Cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67732-025-04 118 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/24/2009

Labeler - Duane Reade (011988995)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
Name Address ID/FEI Operations
Aaron Industries, Inc. 101896231 manufacture, analysis

Revised: 10/2009 Duane Reade



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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