Delsym12 Hour Cough Relief

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

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 63824-171-63 1 BOTTLE In 1 CARTON contains a BOTTLE 1 89 mL In 1 BOTTLE This package is contained within the CARTON (63824-171-63) 2 63824-171-65 1 BOTTLE In 1 CARTON contains a BOTTLE 2 148 mL In 1 BOTTLE This package is contained within the CARTON (63824-171-65) 3 63824-171-75 12 BOTTLE In 1 CARTON contains a BOTTLE 3 15 mL In 1 BOTTLE This package is contained within the CARTON (63824-171-75)

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: 12/2009Reckitt Benckiser, Inc.

More Delsym12 Hour Cough Relief resources

• Delsym12 Hour Cough Relief Side Effects (in more detail)
• Delsym12 Hour Cough Relief Use in Pregnancy & Breastfeeding
• Delsym12 Hour Cough Relief Drug Interactions
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