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NDC 63868-0222-20 Cough Relief 15 mg/1 Details

Cough Relief 15 mg/1

Cough Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. 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: 63868-0222-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	63868-0222
Product ID	63868-222_52e5aec2-ebdb-4096-bb67-b96772571fd1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cough Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	DEXTROMETHORPHAN HYDROBROMIDE
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	Chain Drug Marketing Association Inc.
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	2024-12-31

Package

Package Images

NDC 63868-0222-20 (63868022220)

Pricing Information	N/A
NDC Package Code	63868-222-20
Billing NDC	63868022220
Package	1 BOTTLE in 1 CARTON (63868-222-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2017-07-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 50844352-5ef3-4d01-a7ee-b60a332cd66d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

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 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	take 2 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Other information

store at room temperature 15-30°C (59-86°F)
avoid excessive heat above 40°C (104°F)
protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions or comments?

Call toll free: 248-449-9300

PRINCIPAL DISPLAY PANEL

ADULT LONG-LASTING Cough Relief

Dextromethorphan HBr, USP 15 mg 20 Softgels

NDC 63868-222-20

*Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®

INGREDIENTS AND APPEARANCE

COUGH RELIEF

dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-222
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red (clear)	Score	no score
Shape	capsule (oval)	Size	13mm
Flavor		Imprint Code	PC6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-222-20	1 in 1 CARTON	07/13/2017
1		20 in 1 BOTTLE; 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	07/13/2017

Labeler - Chain Drug Marketing Association Inc. (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(63868-222) , analysis(63868-222)

Revised: 12/2019

Document Id: 52e5aec2-ebdb-4096-bb67-b96772571fd1

Set id: 50844352-5ef3-4d01-a7ee-b60a332cd66d

Version: 2

Effective Time: 20191230