Delsym (dextromethorphan) Suspension Extended-release ®

Delsym (dextromethorphan) Suspension Extended-release ®
SPL v2
SPL
SPL Set ID 56f5f9d1-54a6-48a5-8033-efc29e632479
Route
ORAL
Published
Effective Date 2016-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Polistirex Citric Acid Monohydrate Edetate Disodium Ethylcelluloses Fd&c Yellow No. 6 High Fructose Corn Syrup Methylparaben Polyethylene Glycol 3350 Polysorbate 80 Propylene Glycol Propylparaben Water Sucrose Tragacanth Xanthan Gum

Identifiers & Packaging

Marketing Status
NDA Active Since 2011-08-19

Description

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

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

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224

Section 50565-1

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

Section 50566-9

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. Stop use and ask a doctor if

Section 50570-1

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. Do not use

Section 53414-9

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

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?

1-888-963-3382

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, 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

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)
Delsym (dextromethorphan) (dextromethorphan) Suspension, Extended Release

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)

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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. Stop use and ask a doctor if

Section 50570-1 (50570-1)

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. Do not use

Section 53414-9 (53414-9)

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

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?

1-888-963-3382

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, 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

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)
Delsym (dextromethorphan) (dextromethorphan) Suspension, Extended Release (DELSYM (DEXTROMETHORPHAN) (DEXTROMETHORPHAN) SUSPENSION, EXTENDED RELEASE)

Advanced Ingredient Data


Raw Label Data

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