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Night Time Cough by Kareway Product, Inc.

Medically reviewed on July 11, 2018

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Kareway Product, Inc.
NDC Code: 67510-0503

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 (in each 30 ml dose cup)


Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Usestemporarily relieves common 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 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

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 Relief

NIGHT TIME COUGH 
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0503
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 
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 CodePackage Description
1NDC:67510-0503-4120 mL in 1 BOTTLE
2NDC:67510-0503-6177 mL in 1 BOTTLE
3NDC:67510-0503-1295 mL in 1 BOTTLE
4NDC:67510-0503-2354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/11/2012
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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