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NDC 63824-0175-75 Delsym 30 mg/5mL Details

Delsym 30 mg/5mL

Delsym is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is DEXTROMETHORPHAN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 63824-0175-75
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	63824-0175
Product ID	63824-175_6636ee1b-6c5c-4a0f-8c96-d0f94b0e84fa
Associated GPIs	4310203060G110
GCN Sequence Number	004630
GCN Sequence Number Description	dextromethorphan polistirex SUS ER 12H 30 MG/5 ML ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17802
HICL Sequence Number	010295
HICL Sequence Number Description	DEXTROMETHORPHAN POLISTIREX
Brand/Generic	Brand
Proprietary Name	Delsym
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/5mL
Substance Name	DEXTROMETHORPHAN
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA018658
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63824-0175-75 (63824017575)

Pricing Information	N/A
NDC Package Code	63824-175-75
Billing NDC	63824017575
Package	1 BOTTLE in 1 CARTON (63824-175-75) / 15 mL in 1 BOTTLE
Marketing Start Date	2010-05-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e3e1d126-76c2-4776-8ce0-449625b7e6ba Details

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 63824-175-65

Delsym®

Dextromethorphan Polistirex

Extended-Release Suspension (Cough Suppressant)

COUGH

12

HOUR

COUGH RELIEF

Orange

Flavored Liquid

148 mL (5 fl oz)

Day or Night

SULFITE FREE

ALCOHOL FREE

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

INGREDIENTS AND APPEARANCE

DELSYM

dextromethorphan suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-175
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63824-175-63	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:63824-175-65	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:63824-175-75	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:63824-175-22	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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018658	05/04/2010

Labeler - RB Health (US) LLC (081049410)

Revised: 6/2022

Document Id: 6636ee1b-6c5c-4a0f-8c96-d0f94b0e84fa

Set id: e3e1d126-76c2-4776-8ce0-449625b7e6ba

Version: 12

Effective Time: 20220613

Search by Drug Name or NDC

NDC 63824-0175-75 Delsym 30 mg/5mL Details

Delsym 30 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63824-0175-75 (63824017575)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e3e1d126-76c2-4776-8ce0-449625b7e6ba Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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