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Name:Nighttime Cough
Manufacturer:Hyvee Inc
Category:Over-the-counter (OTC) Marketed Drugs


Hy-Vee Night Time Cough Drug Facts

NIGHTTIME COUGH - dextromethorphan hydrobromide and doxylamine succinate liquid 
HyVee 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.

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Hy-Vee Night Time Cough Drug Facts

Active ingredient (in each 15 mL tablespoon)

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

  • 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 sleepy

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma or emphysema

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 for 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.

Directions

  • take only as recommended
  • use dose cup
  • do not exceed 4 doses per 24 hours
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 insure correct dosing

Other information

  • each TBSP contains: sodium 15 mg
  • store at 20°-25°C (68°-77°F)

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 or comments?

1-800-719-9260

Principal Display Panel

See Labeling Changes

Compare to Vicks® NyQuil® Cough active ingredients

Night Time

Cough

Cherry Flavor

All Night Cough Relief

Dextromethorphan HBr – Cough

Doxylamine Succinate – Sneezing, Runny Nose

10% Alcohol

Cough Suppressant, Antihistamine

Night Time Cough Label

Night Time Cough Label


NIGHTTIME COUGH 
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-668
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg  in 15 mL
Product Characteristics
Color RED (Dark Red) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42507-668-30 177 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/20/2003

Labeler - HyVee Inc (006925671)

Revised: 06/2009 HyVee Inc



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


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