DEXTROMETHORPHAN HBR- dextromethorphan hbr capsule, liquid filled
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rugby 44-732-Delisted

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 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

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?

1-800-645-2158

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

DEXTROMETHORPHAN HBR
dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1323
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)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

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:0536-1323-34	1 in 1 PACKAGE	10/30/2020	12/03/2023
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	10/30/2020	12/03/2023

Labeler - Rugby Laboratories (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0536-1323)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0536-1323)

Revised: 6/2023

Document Id: 148f1789-88d3-4241-9524-c4e813fbda02

Set id: 5eef145a-e05b-4e81-a3a1-c55c458fe639

Version: 4

Effective Time: 20230615

Rugby Laboratories