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NDC 46122-0679-60 Cough Gels 15 mg/1 Details

Cough Gels 15 mg/1

Cough Gels is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. 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: 46122-0679-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	46122-0679
Product ID	46122-679_ea21a124-3d67-4367-8467-5bcda5995b99
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	Cough Gels
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	Amerisource Bergen
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	n/a

Package

Package Images

NDC 46122-0679-60 (46122067960)

Pricing Information	N/A
NDC Package Code	46122-679-60
Billing NDC	46122067960
Package	1 BOTTLE, PLASTIC in 1 PACKAGE (46122-679-60) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e688bf39-b6bc-42ea-bbaf-8ea7d42724e6 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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?

1-800-426-9391

Principal display panel

Good

Neighbor

Pharmacy®

Compare to Robitussin® CoughGels®

active ingredient*

NDC 46122-679-60

8 HOURS

Cough Gels

dextromethorphan HBr, USP 15 mg

Cough Suppressant

•non-drowsy

20 Liquid-filled

Capsules | 15 mg Each

Actual Size

GOOD NEIGHBOR PHARMACY

SATISFACTION

GUARANTEED

BRAND PRODUCTS

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

Distributed By

AmerisourceBergen

1300 Morris Drive

Chesterbrook,

PA 19087

Questions or Concerns?

www.mygnp.com

Good Neighbor Pharmacy 44-732

INGREDIENTS AND APPEARANCE

COUGH GELS

dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-679
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 (clear)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	732
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-679-60	1 in 1 PACKAGE	11/11/2020	07/30/2023
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	11/11/2020	07/30/2023

Labeler - Amerisource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(46122-679)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(46122-679)

Revised: 4/2022

Document Id: ea21a124-3d67-4367-8467-5bcda5995b99

Set id: e688bf39-b6bc-42ea-bbaf-8ea7d42724e6

Version: 3

Effective Time: 20220406