drug facts

drug facts
SPL v6
SPL
SPL Set ID 13eb459c-3075-4038-8062-9ee7175b2ab9
Route
oral
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (200 mg)
Inactive Ingredients
anhydrous citric acid fd&c red no. 40 dextrose glycerin high fructose corn syrup menthol water saccharin sodium sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-12-31

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, 20 mg Guaifenesin, 200 mg


Medication Information

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 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, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Description

Dextromethorphan HBr, 20 mg Guaifenesin, 200 mg

Principal Display Panel

*Compare to the active ingredients in ROBITUSSIN® Peak Cold Cough & Chest Congestion DM

NON-DROWSY

Tussin DM

Cough & Chest

Dextromethorphan HBr/Cough suppressant

Guaifenesin/Expectorant

Relieves: Cough, chest congestion and mucus

Adult formula, For ages 12 and over

Alcohol Free

FL OZ (mL)

*This product is not manufactured or distributed by PFIZER CONSUMER HEALTHCARE, distributed by ROBITUSSIN® Peak Cold Cough and Chest Congestion DM.

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

DISTRIBUTED BY; WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

Questions?

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

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.
Package Label
WinCO Non-Drowsy Tussin DM
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.

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years:do not use
Other Information (Other information)
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red 40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Principal Display Panel

*Compare to the active ingredients in ROBITUSSIN® Peak Cold Cough & Chest Congestion DM

NON-DROWSY

Tussin DM

Cough & Chest

Dextromethorphan HBr/Cough suppressant

Guaifenesin/Expectorant

Relieves: Cough, chest congestion and mucus

Adult formula, For ages 12 and over

Alcohol Free

FL OZ (mL)

*This product is not manufactured or distributed by PFIZER CONSUMER HEALTHCARE, distributed by ROBITUSSIN® Peak Cold Cough and Chest Congestion DM.

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

DISTRIBUTED BY; WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

Questions?

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

Do Not Use (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.
Package Label
WinCO Non-Drowsy Tussin DM
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data


Raw Label Data

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