Children's Delsym ®

Children's Delsym ®
SPL v7
SPL
SPL Set ID d26b5143-aa07-4114-a6ba-4f503aadd46f
Route
ORAL
Published
Effective Date 2022-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 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 Completed Since 2013-03-31 Until 2019-08-31

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 your child 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 use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Section 55105-1
Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give 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
Age (year) Dose (mL)
children 6 to under 12 years of age 5 mL - 10 mL every 4 hours
children 4 to under 6 years of age 2.5 mL - 5 mL every 4 hours
children under 4 years of age do not use
Questions?

1-866-682-4639

You may also report side effects to this phone number.

Other Information
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, 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 the Child Has
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 118 Ml Bottle Carton

NDC 63824-214-64



Ages 4 Years +

Children's



Delsym ®

COUGH + ®



Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)



Guaifenesin (Expectorant)

  • Relieves Cough
  • Relieves Chest



    Congestion
  • Thins &



    Loosens



    Mucus

Cherry Flavor

4 fl oz (118 mL)


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 your child 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 use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give 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
Age (year) Dose (mL)
children 6 to under 12 years of age 5 mL - 10 mL every 4 hours
children 4 to under 6 years of age 2.5 mL - 5 mL every 4 hours
children under 4 years of age do not use
Questions?

1-866-682-4639

You may also report side effects to this phone number.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, 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 the Child Has (Ask a doctor before use if the child has)
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 63824-214-64



Ages 4 Years +

Children's



Delsym ®

COUGH + ®



Chest Congestion

DM

Dextromethorphan HBr (Cough Suppressant)



Guaifenesin (Expectorant)

  • Relieves Cough
  • Relieves Chest



    Congestion
  • Thins &



    Loosens



    Mucus

Cherry Flavor

4 fl oz (118 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)