Delsym suspension, extended release

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Drug Facts

Active ingredient (in each 5 ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

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

Warnings

Otc - do not use section

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.

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)

Otc - stop use section

Stop use and ask a doctor ifcough 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.

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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

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

Other information

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

Inactive ingredients

citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Questions?

1-888-963-3382You may also report side effects to this phone number.

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Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011

Ingredients and appearance - Product information

Delsym suspension, extended release- Dextromethorphan

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63824-176
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan ( UNII: 7355X3ROTS)( Dextromethorphan - UNII: 7355X3ROTS ) 30 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Polistirex ( UNII: 5H9W9GTW27)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Edetate disodium ( UNII: 7FLD91C86K)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Methylparaben ( UNII: A2I8C7HI9T)
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Sucrose ( UNII: C151H8M554)
Tragacanth ( UNII: 2944357O2O)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Flavor ORANGE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA018658 USA

Labeler - Reckitt Benckiser LLC( 094405024)

Principal display panel - 148 ml bottle carton

NDC 63824-176-65

Delsym ®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH
for
Children
& Adults

DAY
OR
NIGHT

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

148 mL (5 fl oz)

Alcohol-free