Qch Adult Tussin Dm Sugar Free 545

Qch Adult Tussin Dm Sugar Free 545
SPL v2
SPL
SPL Set ID 17cb91f0-32ec-9e0f-e063-6394a90a0509
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Anhydrous Citric Acid Glycerin Menthol Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-08

Description

Dextromethorphan HBr, USP 20 mg  Guaifenesin, USP 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr, USP 20 mg  Guaifenesin, USP 200 mg

Use(s)
  • 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


Warnings

.

Directions
  • shake well before using 
  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided 
  • keep dosing cup with product 
  • ml=milliliter 
  • this adult product is not intended for use in children under 12 years of age


Age  Dose 
 adults & children  12 years & over  20 mL every 4 Hours
 Children under 12 years  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.

Other Information
  • each 20 mL contains: sodium 15 mg
  • store at 20-25oC (68-77oF)
  • do not refrigerate
Active Ingredient(s)

Dextromethorphan HBr, USP 20 mg 

Guaifenesin, USP 200 mg

Inactive Ingradients

carboxymethylcellulose sodium, citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water , sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

NDC 83324-025-04

QUALITY CHOICE

* Compare to the Active Ingredients in Robitussin® DM

Adult Tussin DM

Cough Suppressant/ Expectorant

Dextromethorphan HBr 20 mg per 20 mL 

Guaifenesin 200 mg per 20 mL

For Ages 12 & Over 

Helps Control Cough 

Relieves Chest Congestion 

Thins  and Loosens Mucus

Specially Formulated for Diabetics

Non-Drowsy

Sugar Free Dye Free

Peppermint Flavor

4 FL OZ (118 mL)

Stop Use and Ask 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.

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

Use(s) (USE(S))
  • 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 (PURPOSE)

Cough suppressant

Expectorant

Warnings (WARNINGS)

.

Directions (DIRECTIONS)
  • shake well before using 
  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided 
  • keep dosing cup with product 
  • ml=milliliter 
  • this adult product is not intended for use in children under 12 years of age


Age  Dose 
 adults & children  12 years & over  20 mL every 4 Hours
 Children under 12 years  do not use
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.

Other Information (OTHER INFORMATION)
  • each 20 mL contains: sodium 15 mg
  • store at 20-25oC (68-77oF)
  • do not refrigerate
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Dextromethorphan HBr, USP 20 mg 

Guaifenesin, USP 200 mg

Inactive Ingradients (INACTIVE INGRADIENTS)

carboxymethylcellulose sodium, citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water , sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-025-04

QUALITY CHOICE

* Compare to the Active Ingredients in Robitussin® DM

Adult Tussin DM

Cough Suppressant/ Expectorant

Dextromethorphan HBr 20 mg per 20 mL 

Guaifenesin 200 mg per 20 mL

For Ages 12 & Over 

Helps Control Cough 

Relieves Chest Congestion 

Thins  and Loosens Mucus

Specially Formulated for Diabetics

Non-Drowsy

Sugar Free Dye Free

Peppermint Flavor

4 FL OZ (118 mL)

Stop Use and Ask Doctor If (STOP USE AND ASK 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 right away.

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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