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NDC 63868-0345-20 Long Acting Cough Softgels 15 mg/1 Details

Long Acting Cough Softgels 15 mg/1

Long Acting Cough Softgels 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: 63868-0345-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	63868-0345
Product ID	63868-345_23e77caa-a4cb-40f5-8f3e-84fea760e75e
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	Long Acting Cough Softgels
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	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	2023-12-31

Package

Package Images

NDC 63868-0345-20 (63868034520)

Pricing Information	N/A
NDC Package Code	63868-345-20
Billing NDC	63868034520
Package	1 BOTTLE, PLASTIC in 1 PACKAGE (63868-345-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-08-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL adf512c1-ff55-4fc4-9d6b-15fd0b6f1dd1 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 end flap for expiration date and lot number

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?

1-800-426-9391

Principal display panel

QC®

QUALITY

CHOICE

NDC 63868-345-20

*Compare to the active ingredient

in Robitussin® CoughGels®

Long Acting Cough Softgels

Dextromethorphan HBr, USP 15 mg

Cough Suppressant

Up to 8 Hours | For Ages 12 & Over

Non-Drowsy

actual size

20 Softgels

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING

*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

SATISFACTION

100% QC

GUARANTEED

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

44-732

INGREDIENTS AND APPEARANCE

LONG ACTING COUGH SOFTGELS

dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-345
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)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-345-20	1 in 1 PACKAGE	08/12/2020
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	08/12/2020

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(63868-345)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(63868-345)

Revised: 8/2022

Document Id: 23e77caa-a4cb-40f5-8f3e-84fea760e75e

Set id: adf512c1-ff55-4fc4-9d6b-15fd0b6f1dd1

Version: 3

Effective Time: 20220813