DELSYM- dextromethorphan polistirex syrup

Delsym by

Drug Labeling and Warnings

Delsym by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dextromethorphan Polistirex

Purpose

Use(s)

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

Keep Out of Reach of Children

Uses

Use(s)

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

Warnings

Do not use

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)

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children

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

Directions

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

Drug Facts

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

Inactive ingredients

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

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DELSYM 
dextromethorphan polistirex syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-517(NDC:63824-171)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLCELLULOSES (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)
CORN OIL (UNII: 8470G57WFM)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-517-30	90 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018658	09/04/2009

DELSYM 
dextromethorphan polistirex syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-518(NDC:63824-172)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLCELLULOSES (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)
CORN OIL (UNII: 8470G57WFM)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-518-30	90 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 - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK