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NightTime Cough DM Maximum Strength

Medically reviewed on July 11, 2018

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 10mL, DOXYLAMINE SUCCINATE 12.5mg in 10mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-292

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 10 mL)

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves  these symptoms due to hay fever or other upper respiratory allergies
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • controls the impulse to cough to help you sleep

Warnings

Do not use
  • to sedate a child or to make a child sleepy
  • 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.

Ask a doctor before use if you have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

 taking a sedatives or tranquilizers.

When using this product
  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 (1-800-222-1222) right away.

Directions
  • this adult product is not intended for use in children under 12 years of age
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • adults and children 12 years and over: 10 mL every 6 hours
  • children under 12 years: do not use

Other information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol 300, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions?

or to report an adverse event call 800-824-1706 Monday - Friday 9am -4 pm MST  

Principal Display Panel

*Compare to the active ingredients in Robitussin® Maximum Strength NightTime Cough DM

MAXIMUM STRENGTH

Tussin DM

Nighttime Cough

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

Relieves: Cough, Itchy Throat & Runny Nose

Adult Formula, For Ages 12 Years & Over

Alcohol Free

FL OZ (mL)

*This product is not manufactured or distributed by PFIZER CONSUMER HEALTHCARE distributor of ROBITUSSIN® Maximum Strength Nighttime Cough DM.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLEOR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

Package Label

Winco Foods Maximum Strength Tussin DM NightTime Cough

NIGHTTIME COUGH DM  MAXIMUM STRENGTH
dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-292
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
POLYETHYLENE GLYCOL 300 
PROPYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
SODIUM BENZOATE 
XANTHAN GUM 
SODIUM CITRATE 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:67091-292-181 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2016
Labeler - WinCo Foods, LLC (056098817)

 
WinCo Foods, LLC

Further information

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

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