qch adult tussin dm

qch adult tussin dm
SPL v2
SPL
SPL Set ID 17caffa4-a264-7f3e-e063-6394a90ac419
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 fd&c blue no. 1 fd&c red no. 40 glycerin high fructose corn syrup menthol polyethylene glycol, unspecified propylene glycol water sodium benzoate sodium citrate sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2024-05-08

Purpose

Cough suppressant  Expectorant

Description

Dextromethorphan HBr, USP 20 mg  Guaifenesin, USP 200 mg 


Medication Information

Warnings

.

Purpose

Cough suppressant 

Expectorant

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

carboxymethylcellulose sodium, citric acid, FD&C blue 1 dye, FD&C red 40 dye, flavor, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Description

Dextromethorphan HBr, USP 20 mg  Guaifenesin, USP 200 mg 

Principal Display Panel

NDC 83324-023-04

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

Non- Drowsy

Raspberry  Flavor 

4 FL OZ(118 mL)



NDC 83324-023-08

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

Non- Drowsy

Raspberry  Flavor 

8 FL OZ(237 mL)









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


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.

Active Ingredient(s)

Dextromethorphan HBr, USP 20 mg 

Guaifenesin, USP 200 mg 

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

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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Warnings (WARNINGS)

.

Purpose (PURPOSE)

Cough suppressant 

Expectorant

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 
Other Information (OTHER INFORMATION)
  • each 20 mL contains: sodium 15 mg 
  • store at 20-25oC (68-77oF)
  • do not refrigerate
Inactive Ingredients (INACTIVE INGREDIENTS)

carboxymethylcellulose sodium, citric acid, FD&C blue 1 dye, FD&C red 40 dye, flavor, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-023-04

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

Non- Drowsy

Raspberry  Flavor 

4 FL OZ(118 mL)



NDC 83324-023-08

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

Non- Drowsy

Raspberry  Flavor 

8 FL OZ(237 mL)









Use(s) (USE(S))
  • temporarily relieves 
  • cough due too minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 


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.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Dextromethorphan HBr, USP 20 mg 

Guaifenesin, USP 200 mg 

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

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.

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.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.


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Raw Label Data

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