Dextromethorphan HBr capsules

Manufacturer
BIONPHARMA INC. | Ocean Healthcare Pvt Ltd
Effective date
2026-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:03:32

Label at a glance#

ProductDextromethorphan HBr
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Dosage and administration

■ do not take more than 8 capsules in any 24-hour period ■ this 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, or as directed by a doctor children under 12 years do not use

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP, 15 mg

Purpose

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

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 SECTION

Ask a doctor before use if you have ■ cough that is accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - STOP USE SECTION

Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than 8 capsules in any 24-hour period
■ this 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, or as
directed by a doctor
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No.1, FD&C Red No.40, gelatin, glycerin, pharmaceutical imprinting ink, polyethylene glycol 400, povidone, propylene glycol, propyl gallate, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the owners of Robitussin® Long-Acting CoughGels®.

Tamper-Evident: Do not use if printed seal under cap is missing or damaged


Manufactured for:
BIONPHARMA
Princeton, NJ 08540
Code:TN/Drugs/TN00003701

MADE IN INDIA

PML00430

NDC 69452-573-17

L0001304 R0726

60's count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*compare to the active ingredient in
Robitussin® Long-Acting CoughGels®
a+ health TM

dextromethorphan
HBr capsules, 15 mg
cough suppressant
relieves cough for
up to 8 hours
for ages 12 & over
60 SOFTGELS**

**liquid-filled
capsules

image-01image-01

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-57369452-573-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
ndc (package): 69452-573-17
ndc (product): 69452-573
ndc11 (package): 69452057317
spl id: 5a5dde7e-05b9-13e7-e063-6394a90a197e
spl set id: 5a5dde85-8785-8149-e063-6294a90a4d57

Reported adverse events (FAERS/openFDA)#

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