Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 4656e60e-4733-45c1-bf55-d156e45085c6
Route
ORAL
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Glycerin Methylparaben Polyethylene Glycol, Unspecified Povidone Propylene Glycol Saccharin Sodium Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-30

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

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
Directions
  • do not take more than 6 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
  • this adult product is not intended for use in children under 12 years of age
  • adults and children12 years and over: 10 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.

Package Label
BEST CHOICE Sugar Free Cough & Chest Congestion
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, citric acid, flavors, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments?

 Call toll free 1-866-4-REXALL

Principal Display Panel

*Compare to the active ingredients in Robitussin® Sugar-Free Cough+ Chest Congestion DM

ADULT SUGAR-FREE

Tussin Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr 20 mg

COUGH SUPPRESSANT

GUAIFENESIN 200 mg

EXPECTORANT

For relief of:

  • Cough
  • Mucus

Alcohol free

SPECIALLY FORMULATED FOR DIABETICS

FOR AGES 12 & OVER

NON-DROWSY

FL OZ (mL)

*This product is not manufactured or distributed by Haleon group of companies, distributor of Robitussin® Sugar-Free Cough + Chest Congestion DM.

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

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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-hour 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 children12 years and over: 10 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.

Package Label
BEST CHOICE Sugar Free Cough & Chest Congestion
Other Information
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, citric acid, flavors, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments? (Questions or comments?)

 Call toll free 1-866-4-REXALL

Principal Display Panel

*Compare to the active ingredients in Robitussin® Sugar-Free Cough+ Chest Congestion DM

ADULT SUGAR-FREE

Tussin Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr 20 mg

COUGH SUPPRESSANT

GUAIFENESIN 200 mg

EXPECTORANT

For relief of:

  • Cough
  • Mucus

Alcohol free

SPECIALLY FORMULATED FOR DIABETICS

FOR AGES 12 & OVER

NON-DROWSY

FL OZ (mL)

*This product is not manufactured or distributed by Haleon group of companies, distributor of Robitussin® Sugar-Free Cough + Chest Congestion DM.

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

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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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