Night Time Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Night Time Cough

Kareway Product, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 ml dose cup)


Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Night Time Cough Uses


  • 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

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 is accompanied by fever, rash, or persistent headache. 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

  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours

adults and children 12 years and over
2 TBSP (30ml) every 6 hours
children under 12 years
ask a doctor

Night Time Cough Other information

  • each 30mL dose cup contains: sodium 36 mg
  • store at room temperature

Inactive ingredients

alcohol, citric acid, FD and C blue no.1, FD and C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose, xanthan gum

Package label

Night Time Cough ReliefNight Time Cough

Night Time Cough

Dextromethorphan HBr, Doxylamine succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0503
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

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
propylene glycol
water
SACCHARIN SODIUM DIHYDRATE
SODIUM CITRATE
SUCROSE
Sucralose
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67510-0503-4 120 in 1 BOTTLE
2 NDC:67510-0503-6 177 in 1 BOTTLE
3 NDC:67510-0503-1 295 in 1 BOTTLE
4 NDC:67510-0503-2 354 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-07-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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