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NDC 00536-1323-34 Dextromethorphan HBr 15 mg/1 Details

Dextromethorphan HBr 15 mg/1

Dextromethorphan HBr is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

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: 00536-1323-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	00536-1323
Product ID	0536-1323_ecba4eba-ffdb-4196-954c-c3bcaab51658
Associated GPIs	43102030500110
GCN Sequence Number	004622
GCN Sequence Number Description	dextromethorphan HBr CAPSULE 15 MG ORAL
HIC3	H6C
HIC3 Description	ANTITUSSIVES, NON-OPIOID
GCN	17770
HICL Sequence Number	001925
HICL Sequence Number Description	DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Dextromethorphan HBr
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Rugby Laboratories
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	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00536-1323-34 (00536132334)

Pricing Information	N/A
NDC Package Code	0536-1323-34
Billing NDC	00536132334
Package	1 BOTTLE, PLASTIC in 1 PACKAGE (0536-1323-34) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5eef145a-e05b-4e81-a3a1-c55c458fe639 Details

Active ingredient (in each liquid-filled capsule)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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

a cough that occurs with too much phlegm (mucus)
a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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

do not take more than 8 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed
children under 12 years: do not use

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from light, heat and moisture
see bottle for lot number and expiration date

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-645-2158

Principal display panel

Rugby®

NDC 0536-1323-34

Compare to the

active ingredient in

Robitussin® CoughGels®*

Dextromethorphan HBr

USP

15 mg

Cough Suppressant

Up to 8 Hours

For Ages 12 and Over

Non-Drowsy

20 Liquidgels

(Liquid Filled Capsules)

Actual Size

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rev. 10/20

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is

not manufactured

or distributed by

PF Consumer Healthcare 1 LLC,

owner of the

registered

trademark Robitussin®

CoughGels®.

50844 ORG012073209

Product of Dubai

Packaged and

Quality Assured

in the USA

KEEP OUTER

PACKAGE FOR

COMPLETE

PRODUCT

INFORMATION

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

Rev. 10/20 R-17 Re-Order No. 371074

Rugby 44-732

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR

dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1323
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (clear)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	732
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1323-34	1 in 1 PACKAGE	10/30/2020
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/30/2020

Labeler - Rugby Laboratories (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0536-1323)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0536-1323)

Revised: 10/2022

Document Id: ecba4eba-ffdb-4196-954c-c3bcaab51658

Set id: 5eef145a-e05b-4e81-a3a1-c55c458fe639

Version: 3

Effective Time: 20221029