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Night Time

Hannaford Brothers Company

Hannaford Bros. Co. Night Time Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 15 mL tablespoon)

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Cough suppressant

Antihistamine

Night Time 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

Night Time 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?

1-800-213-9040

Principal Display Panel

Compare to Vicks® NyQuil® Cough active ingredients

See Labeling Changes

Cough Suppressant, Antihistamine

Night Time

Cough

All Night Cough Relief

Cough - Dextromethorphan HBr

Sneezing, Runny Nose - Doxylamine Succinate

Cherry Flavor

Alcohol 10%

Night Time
Night Time Cough Label

Night Time

Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41268-668
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Product Characteristics

Color
RED (Dark Red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41268-668-38 296 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-09-26


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Be sure to consult your doctor before taking any medication!
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