Delsym

Manufacturer
Rebel Distributors Corp
Effective date
2011-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:55

Key Label Information#

Active Ingredients And Purpose

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

Uses

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

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 And Dosage

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

Other Label Information

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

Label Images#

4abb0813-e080-4bae-b829-e2c29d0a8d4f-01
4abb0813-e080-4bae-b829-e2c29d0a8d4f-01
4abb0813-e080-4bae-b829-e2c29d0a8d4f-02
4abb0813-e080-4bae-b829-e2c29d0a8d4f-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373128Delsym 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN1
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN1
137312812 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension [Delsym]SBD1
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD1
1373128Delsym (dextromethorphan polistirex equivalent to 30 mg per 5 ML dextromethorphan hydrobromide) 12 HR Extended Release SuspensionSY1
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY1
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-517-302019-09-24C16284748780-1934fe258-4899-48b1-e053-8cdaa90a720aDrug Facts
21695-518-302019-09-24C16284748780-1934fe258-4899-48b1-e053-8cdaa90a720aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-517-30Delsym90 mL in 1 BOTTLESYRUP901
21695-518-30Delsym90 mL in 1 BOTTLESYRUP901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-517DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_4abb0813-e080-4bae-b829-e2c29d0a8d4f.zip
21695-518DELSYM (DEXTROMETHORPHAN POLISTIREX) SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_4abb0813-e080-4bae-b829-e2c29d0a8d4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-171-63ML - Milliliter63824-1711bddda2c-79bb-42f5-b372-f91183329d6d12012-07-24
63824-171-65ML - Milliliter63824-171abd6b6f5-948c-4c45-a390-9bae52a45eda12012-07-24
63824-172-63ML - Milliliter63824-172d072cd6c-371b-475e-b764-697fe8c81a5e12012-07-24
63824-172-65ML - Milliliter63824-1727b8e5c0f-75f1-4eb6-8980-0a79e87827e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHANACTIVE INGREDIENT7355X3ROTS1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CORN OILINACTIVE INGREDIENT8470G57WFM1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4B1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5P1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TRAGACANTHINACTIVE INGREDIENT2944357O2O1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-51721695-517-30
63824-171
21695-51821695-518-30
63824-172

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Polistirex

Purpose

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Uses

INDICATIONS & USAGE SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML