Delsym12 Hour Cough Relief

Generic Name: dextromethorphan
Dosage Form: extended-release suspension

Delsym
12 Hour Cough Relief
Grape

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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

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.

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)

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.

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

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
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°-25°C (68°-77°F)
  • dosing cup provided

Inactive ingredients

citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Questions?

1-888-963-3382

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

PRINCIPAL DISPLAY PANEL - 89 mL Carton

NDC 63824-171-63

Delsym®

dextromethorphan polistirex
extended-release suspension

COUGH SUPPRESSANT

SEE NEW DOSING
DIRECTIONS

12
HOUR
Cough Relief

Grape-Flavored Liquid

Alcohol-free

89 mL (3 fl oz)

DELSYM 
dextromethorphan suspension, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-171
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Polistirex  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63824-171-63 1 BOTTLE (BOTTLE) in 1 CARTON
1 89 mL in 1 BOTTLE
2 NDC:63824-171-65 1 BOTTLE (BOTTLE) in 1 CARTON
2 148 mL in 1 BOTTLE
3 NDC:63824-171-75 12 BOTTLE (BOTTLE) in 1 CARTON
3 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018658 09/04/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009
 
Reckitt Benckiser, Inc.



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