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NDC 36800-0415-15 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 Topco Associates LLC. 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: 36800-0415-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	36800-0415
Product ID	36800-415_12c6e440-72d2-4bfc-b45d-60d28efa68a3
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	Topco Associates 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	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0415-15 (36800041515)

Pricing Information	N/A
NDC Package Code	36800-415-15
Billing NDC	36800041515
Package	1 BOTTLE in 1 CARTON (36800-415-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2016-07-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a35e6bb-9d66-496a-b687-cd09c93306a0 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 useif 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 special and white edible ink

Questions or comments?

Call toll free: 1-888-423-0139

PRINCIPAL DISPLAY PANEL - Carton Label

TopCare Cough Relief

Dextromethorphan HBr, USP 15 mg 20 SOFTGELS

NDC 36800-415-15

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

PRINCIPAL DISPLAY PANEL - Bottle Label