DELSYM- dextromethorphan suspension, extended release

Delsym by

Drug Labeling and Warnings

Delsym by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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 such 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, 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
• 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 20-25°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

Questions?

1-866-682-4639
You may also report side effects to this phone number.

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Distributed by:
RB Health (US)
Parsippany, NJ
07054-0224

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC: 63824-171-65

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

12
HOUR
COUGH RELIEF®

Day or Night

Grape
Flavored Liquid

148 mL (5 fl oz)

SULFITE FREE
ALCOHOL FREE

INGREDIENTS AND APPEARANCE

DELSYM 
dextromethorphan suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-171
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Polistirex (UNII: 5H9W9GTW27)
anhydrous citric acid (UNII: XF417D3PSL)
D&C Red NO. 33 (UNII: 9DBA0SBB0L)
edetate disodium (UNII: 7FLD91C86K)
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-171-63	1 in 1 CARTON	05/04/2010
1		89 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 63824-171-65	1 in 1 CARTON	05/04/2010
2		148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
3	NDC: 63824-171-75	1 in 1 CARTON	05/04/2010
3		15 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
4	NDC: 63824-171-22	2 in 1 CELLO PACK	05/04/2010
4		1 in 1 CARTON
4		148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018658	05/04/2010

Labeler - RB Health (US) LLC (081049410)