Delsym

Delsym
SPL v5
SPL
SPL Set ID 00f8f5b4-f5a8-4dcf-8133-15964ad4801e
Route
ORAL
Published
Effective Date 2022-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Polistirex Anhydrous Citric Acid D&c Red No. 33 Edetate Disodium Ethylcellulose, Unspecified Fd&c Blue No. 1 High Fructose Corn Syrup Methylparaben Polyethylene Glycol 3350 Polysorbate 80 Propylene Glycol Propylparaben Water Sucrose Tragacanth Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
NDA Active Since 2018-12-17

Description

Drug Facts

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

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, cough comes back, or occurs with fever, rash or headache that lasts. 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.

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
  • mL = milliliter
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.

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

citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, 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

Ask A Doctor Before Use If You Have
  • chronic cough that lasts as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Ndc 17856 0172 01delsym® Dextromethorphan Polistirex


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, cough comes back, or occurs with fever, rash or headache that lasts. 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.

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
  • mL = milliliter
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.

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 anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, 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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • chronic cough that lasts as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Ndc 17856 0172 01delsym® Dextromethorphan Polistirex (NDC 17856-0172-01Delsym® Dextromethorphan Polistirex)


Advanced Ingredient Data


Raw Label Data

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