DELSYM (DEXTROMETHORPHAN)- dextromethorphan suspension, extended release

Delsym (Dextromethorphan) by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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, 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

Questions?

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC: 63824-177-65
Ages 4+

Children's
Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

Day
or
Night

12
HOUR
COUGH RELIEF™

Orange
Flavored Liquid

148 mL (5 fl oz)
For Children & Adults

INGREDIENTS AND APPEARANCE

DELSYM (DEXTROMETHORPHAN) 
dextromethorphan suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-177
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)
citric acid monohydrate (UNII: 2968PHW8QP)
edetate disodium (UNII: 7FLD91C86K)
ethylcellulose, unspecified (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
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-177-63	1 in 1 CARTON	08/19/2011
1		89 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 63824-177-65	1 in 1 CARTON	07/01/2017
2		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	08/19/2011

Labeler - RB Health (US) LLC (081049410)