Delsym

Delsym
SPL v19
SPL
SPL Set ID 2ac3cac7-5980-4ff5-9939-d494c3daa9d2
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Polistirex Citric Acid Edetate Disodium Ethylcellulose Ki5 High Fructose Corn Syrup Methylparaben Peg-75 Peg-20 Sorbitan Oleate Propylene Glycol Propylparaben Aqua Sucrose Tragacanth Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
NDA Active Since 2010-05-04
Description

Drug Facts

Purpose

Cough suppressant

How Supplied

Product: 50090-0224 NDC: 50090-0224-0 89 mL in a BOTTLE / 1 in a CARTON

Medication Information

Purpose

Cough suppressant

How Supplied

Product: 50090-0224

NDC: 50090-0224-0 89 mL in a BOTTLE / 1 in a CARTON

Description

Drug Facts

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • 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 50566-9

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.

Section 50569-3

Ask a doctor before use if you have

  • chronic cough that lasts such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
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.

Directions
  • shake bottle well before use
  • 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 10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 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.

Dextromethorphan
Other Information
  • each 5 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided
Inactive Ingredients

citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Active Ingredient (in Each 5 Ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Structured Label Content

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • 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 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • chronic cough that lasts such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
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.

Purpose

Cough suppressant

Directions
  • shake bottle well before use
  • 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 10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 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.

How Supplied (HOW SUPPLIED)

Product: 50090-0224

NDC: 50090-0224-0 89 mL in a BOTTLE / 1 in a CARTON

Dextromethorphan
Other Information (Other information)
  • each 5 mL contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.286270 · Updated: 2026-03-14T23:07:47.363489