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Delsym by Rebel Distributors Corp

Medically reviewed on January 12, 2018

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN 30mg in 5mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-517

Drug Facts

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

DELSYM 
dextromethorphan polistirex syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-517(NDC:63824-171)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
EDETATE DISODIUM 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
HIGH FRUCTOSE CORN SYRUP 
METHYLPARABEN 
POLYETHYLENE GLYCOL 3350 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCROSE 
TRAGACANTH 
CORN OIL 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:21695-517-3090 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865809/04/2009
DELSYM 
dextromethorphan polistirex syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-518(NDC:63824-172)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN (DEXTROMETHORPHAN) DEXTROMETHORPHAN30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
EDETATE DISODIUM 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
HIGH FRUCTOSE CORN SYRUP 
METHYLPARABEN 
POLYETHYLENE GLYCOL 3350 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCROSE 
TRAGACANTH 
CORN OIL 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:21695-518-3090 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865809/04/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

See Also

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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