DEXTROMETHORPHAN HBR 15 MG

Manufacturer: AMZ789 LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd
Effective date: 2025-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:51:38

Label at a glance#

ProductDEXTROMETHORPHAN HBR 15 MG

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 15 mg

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1090487	dextromethorphan HBr 15 MG Oral Capsule	PSN	2
1090487	dextromethorphan hydrobromide 15 MG Oral Capsule	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73629-005-10	DEXTROMETHORPHAN HBR 15 MG	100 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73629-005	DEXTROMETHORPHAN HBR 15 MG CAPSULE, LIQUID FILLED [AMZ789 LLC]	2	Current NDC, Legacy NDC, 1 package rows	20250110_e2175017-6a0d-0155-e053-2995a90a65d6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

DEXTROMETHORPHAN HBR 15 MG
WATER
FD&C RED NO. 40
POLYETHYLENE GLYCOL 400
POVIDONE
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GELATIN
PROPYLENE GLYCOL
FD&C BLUE NO. 1
GLYCERIN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73629-005	73629-005-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE	FZ989GH94E	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GELATIN	2G86QN327L	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROMETHORPHAN HBR 15 MG	DEXTROMETHORPHAN HBR 15 MG	AMZ789 LLC	e2175017-6a0d-0155-e053-2995a90a65d6	2025-01-08	Warnings	Exact identifier ndc (package): 73629-005-10 ndc (product): 73629-005 ndc11 (package): 73629000510 spl id: 2b3b3017-9dd9-a696-e063-6394a90a4835 spl set id: e2175017-6a0d-0155-e053-2995a90a65d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.