Tussin Dm 

Tussin Dm 
SPL v2
SPL
SPL Set ID 21041535-6021-43c6-97a6-75e5bd3be0ad
Route
ORAL
Published
Effective Date 2019-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-02

Description

Drug Facts

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

          dose

adults and children 12 years and over

          2 softgels every 4 hours

children under 12 years

          do not use

Other Information
  • store at room temperature 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call: 1-855-215-8180

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
Active Ingredients (in Each Softgel)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Principal Display Panel  carton Label

CAREONE TUSSIN DM 20ct

NDC 41520-986-08

*Compare to the active ingredients in Robitussin® Maximum Strength Cough Plus Chest Congestion DM


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
Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age

age

          dose

adults and children 12 years and over

          2 softgels every 4 hours

children under 12 years

          do not use

Other Information (Other information)
  • store at room temperature 15-30°C (59-86°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments? (Questions or comments?)

Call: 1-855-215-8180

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
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Principal Display Panel  carton Label (PRINCIPAL DISPLAY PANEL - Carton Label)

CAREONE TUSSIN DM 20ct

NDC 41520-986-08

*Compare to the active ingredients in Robitussin® Maximum Strength Cough Plus Chest Congestion DM


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)