Delsym ®

Delsym ®
SPL v9
SPL
SPL Set ID 8252cdec-b668-4450-b045-e093479ab542
Route
ORAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Edetate Disodium Fd&c Red No. 40 Anhydrous Citric Acid Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Trisodium Citrate Dihydrate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50567-7

When using this product do not use more than directed

Section 50570-1

Do not useif 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.

Section 55105-1
Active ingredients (in each 20 mL) Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Questions?

1-866-682-4639

Other Information
  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin(soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient
, xanthan gum

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 180 Ml Bottle Label

NDC 63824-213-66

Delsym ®

COUGH+™



CHEST



CONGESTION

DM

Dextromethorphan HBr (Cough Suppressant)



Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus

6 fl oz (180 mL)

For Ages 12+

Cherry

Flavored Liquid




Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50570-1 (50570-1)

Do not useif 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.

Section 55105-1 (55105-1)
Active ingredients (in each 20 mL) Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Questions?

1-866-682-4639

Other Information (Other information)
  • each 20 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin(soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

may contain this ingredient
, xanthan gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 180 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label)

NDC 63824-213-66

Delsym ®

COUGH+™



CHEST



CONGESTION

DM

Dextromethorphan HBr (Cough Suppressant)



Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus

6 fl oz (180 mL)

For Ages 12+

Cherry

Flavored Liquid




Advanced Ingredient Data


Raw Label Data

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