FDA.reportPublic FDA data

Dextromethorphan HBr

Manufacturer
Rugby Laboratories | LNK International, Inc.
Effective date
2023-06-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:29:57

Label at a glance#

ProductDextromethorphan HBr
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Dosage and administration

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

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from light, heat and moisture see bottle for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 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

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
  • see bottle for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-645-2158

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1323-34

Compare to the
active ingredient in
Robitussin® CoughGels®*

Dextromethorphan HBr
USP
15 mg

Cough Suppressant

Up to 8 Hours
For Ages 12 and Over
Non-Drowsy

20 Liquidgels
(Liquid Filled Capsules)

Actual Size

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
www.rugbylaboratories.com

Rev. 10/20

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

*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

KEEP OUTER
PACKAGE FOR
COMPLETE
PRODUCT
INFORMATION

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Rev. 10/20   R-17   Re-Order No. 371074

Rugby 44-732
Rugby 44-732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1323-34EA - Each0536-132349be67ad-21ff-459b-aeb7-9be1f88db6de12021-02-05

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13230536-1323-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT

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
148f1789-88d3-4241-9524-c4e813fbda025eef145a-e05b-4e81-a3a1-c55c458fe6392023-06-15WarningsExact identifier
spl id: 148f1789-88d3-4241-9524-c4e813fbda02
spl set id: 5eef145a-e05b-4e81-a3a1-c55c458fe639

Reported adverse events (FAERS/openFDA)#

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